Fix the product in hand
Record brand, generic name, dosage form, strength, pack and market together. Do not substitute a similar medicine name.
PHARMACOVIGILANCE · OFFICIAL ROUTES
For medicine safety, return to the official record.
Pharmacovigilance monitors new safety information, risk communications and label changes after authorisation. This page provides official routes and a checking method only: read every safety notice, suspected adverse-reaction report, recall or regulator page in its product, market, dosage-form, strength and date context.
HOW TO READ A SAFETY RECORD
Start with the exact product, market and notice date
Suspected adverse-reaction reports help detect and assess safety signals. First match the product, dosage form, strength, market and notice date, then bring the symptom timeline and complete medicine list to a professional. A report or headline alone does not prove causation or decide stopping, switching or changing an amount.
GLOBAL SAFETY REVIEW FRAMEWORK
Every dossier starts with a product route, then enters the global official safety network
We do not turn “global” into an unverifiable promise of real-time coverage. Every dossier first binds to a publicly readable product-level label or regulator record; only official safety records checked against the named product, dosage form, market and date appear on a medicine page. Market gateways support further checking, not automatic risk matching.
286dossiers with a medicine-specific public product route
171dossiers retaining multiple reviewed market or version documents
15reviewed market-level official safety gateways
30dated official safety records with reviewed scope
SCOPED OFFICIAL RECORDS · REVIEWED 22 AUGUST 2026
Reviewed official safety records with scoped matches
Each official notice appears once. If it concerns several catalogued medicines, the same card lists every matching dossier. First check the notice date, market, product and dosage form before opening the source record.
Searches brand, generic name and record title. No result does not mean that a medicine has no risk or newer notice in another market.
No matching reviewed record is currently listed. Return to the medicine dossier for its product-level label, then use the official market gateways below to continue checking the product in hand.
RYTARY · RytaryOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for RYTARY and other carbidopa/levodopa products
On 20 Mar 2026, FDA issued a Drug Safety Communication requiring every carbidopa/levodopa product to add a warning about vitamin B6 deficiency and associated seizures; the current RYTARY label includes this warning. The communication cannot determine an individual's vitamin B6 status, need for testing or supplementation, and does not support self-stopping, switching to SINEMET or STALEVO, changing capsule counts or altering timing. Use local emergency services for a seizure, loss of consciousness or ongoing convulsions; have the prescribing team assess other suspected symptoms using the exact product and complete medicine list.
Open the official source record ↗reviewed 2026-08-22CREXONT · CrexontOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for CREXONT and other carbidopa/levodopa products
On 20 Mar 2026, FDA issued a Drug Safety Communication requiring every carbidopa/levodopa product to add a warning about vitamin B6 deficiency and associated seizures; the current CREXONT label includes this warning. It cannot determine an individual's deficiency, testing or supplementation need and does not support self-stopping, switching to RYTARY, SINEMET or STALEVO, changing capsule count or altering timing. Use local emergency services for a seizure, loss of consciousness or ongoing convulsions; have the prescribing team assess other suspected symptoms using the exact product and complete medicine list.
Open the official source record ↗reviewed 2026-08-22Sinemet · SINEMETOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for carbidopa/levodopa products
On 2026-03-20, FDA issued a Drug Safety Communication requiring all carbidopa/levodopa products to add a warning about vitamin B6 deficiency and associated seizures; the communication explicitly lists Sinemet and Sinemet CR. It covers multiple forms and routes, but cannot determine an individual’s risk, need for testing or supplementation, or support self-stopping, form changes or dose changes. Review the exact product and current label with the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Wegovy · 司美格鲁肽Open the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: related labelling change for Wegovy and other GLP-1 receptor agonists
On 2026-01-13, FDA issued a Drug Safety Communication requesting removal of existing suicidal-ideation/behavior language from prescribing information for Wegovy (semaglutide), Saxenda and Zepbound; FDA said its comprehensive review did not identify an increased risk with GLP-1 receptor agonists. The communication describes a U.S. regulatory action and named products only. It does not replace the exact product, current target-market label or an individual mental-health assessment; new or worsening mood, behavior or self-harm thoughts require prompt local emergency or clinical support, not self-directed medicine changes.
Open the official source record ↗reviewed 2026-08-22Ozempic · 司美格鲁肽Open the matching dossier and check the product in hand against its current public label
FDA drug alert: specific counterfeit Ozempic 1 mg injection pens in the U.S. supply chain
In its U.S. alert updated on 2025-12-05, FDA said counterfeit Ozempic (semaglutide) 1 mg injection pens had been illegally distributed into the legitimate U.S. supply chain. The notice names lot PAR1229 and a specific EXP/LOT-text placement on the pen as checking cues, and tells U.S. patients not to use products that match its description. This record is limited to the U.S., the described 1 mg pen, lot/labelling features and notice date. It cannot authenticate another pack, apply to another strength, lot or market, or determine whether any individual should use Ozempic. Photo text recognition, visual similarity and an online search do not replace verification of the actual product through a pharmacist, authorised supply chain and local regulator routes.
Open the official source record ↗reviewed 2026-08-22Plavix · Clopidogrel Bisulfate TabletsOpen the matching dossier and check the product in hand against its current public label
FDA pharmacogenomic label record: clopidogrel and CYP2C19
FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling lists clopidogrel (Plavix) with CYP2C19-related labeling information. The table is a U.S. regulator index to where genomic information appears in labeling; it does not mean every user needs screening, that a tested person should self-change a dose, or that another medicine may be substituted independently. Whether to test, how to interpret a result and how it relates to other medicines must be reviewed with the exact product, indication, current label and complete medicine list by the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Coumadin · warfarinOpen the matching dossier and check the product in hand against its current public label
FDA pharmacogenomic label record: warfarin and CYP2C9 / VKORC1
FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling lists warfarin (Coumadin) with CYP2C9 / VKORC1-related labeling information. The table is a U.S. regulator index to where genomic information appears in labeling; it does not mean every user needs screening, that a tested person should self-change a dose, or that another medicine may be substituted independently. Whether to test, how to interpret a result and how it relates to other medicines must be reviewed with the exact product, indication, current label and complete medicine list by the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Bactrim · sulfamethoxazole and trimethoprimOpen the matching dossier and check the product in hand against its current public label
FDA-hosted company recall announcement: specific Amneal sulfamethoxazole/trimethoprim tablets
FDA explicitly says this is a company announcement it posts as a public service and does not endorse the company or product. The announcement concerns only U.S. Amneal sulfamethoxazole/trimethoprim 400 mg/80 mg tablets, three named lots (AM241019, AM241019A, AM241020), and the listed NDCs/packs. It does not apply to Bactrim brand, Bactrim DS, 800 mg/160 mg, another manufacturer, another lot, another market, or any current-product-status conclusion.
Open the official source record ↗reviewed 2026-08-22XYZAL · XyzalOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: rare but severe itching after stopping long-term oral levocetirizine/XYZAL
On 16 May 2025, FDA said rare but potentially severe itching can occur after stopping long-term regular use of oral levocetirizine or cetirizine; the communication covers U.S. prescription and nonprescription products and requires label updates. This regulator record cannot predict an individual event or provide a self-directed stop, restart, taper, switch or antihistamine-combination plan. Discuss planned long-term use, and contact a local pharmacist, prescriber or medical service with the actual pack and complete medicine list if severe itching appears after stopping.
Open the official source record ↗reviewed 2026-09-03Zyrtec · cetirizineOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: rare but severe itching after stopping long-term oral cetirizine/Zyrtec
On 2025-05-16, FDA issued a Drug Safety Communication saying that rare but severe itching can occur after stopping long-term, regular use of oral cetirizine (Zyrtec) or levocetirizine; the communication covers U.S. prescription and over-the-counter label updates. This is a dated U.S. regulator communication tied to named ingredients/products. It cannot determine whether any Zyrtec pack, another allergy medicine, another market or any individual will have this outcome, and it does not support self-stopping, restarting, tapering or switching from this page. Severe itching after stopping needs prompt contact with a local pharmacist, prescribing team or medical service, with the actual pack and complete medicine list.
Open the official source record ↗reviewed 2026-09-03PAXLOVID · PAXLOVIDOpen the matching dossier and check the product in hand against its current public label
FDA drug alert: U.S. authorisation-status change for EUA-labelled PAXLOVID
In an update dated 2024-03-13, FDA said that in the U.S. PAXLOVID labelled for EUA use, including product whose labelled or extended expiration information remained, was no longer authorised for emergency use; the notice directs handling of EUA-labelled product in U.S. distribution and distinguishes NDA-approved labelling. This is U.S.-market information for a specific labelling status and date. It does not determine another market, authenticity of any pack, whether an individual should use PAXLOVID, or whether co-medication can be changed independently. Check the actual pack, the current document for its market and the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Prolia · 地舒单抗Open the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: Boxed Warning for severe hypocalcemia with Prolia (denosumab) in advanced chronic kidney disease
On 2024-01-19, after completing its review, FDA added a Boxed Warning to U.S. Prolia (denosumab) prescribing information about severe hypocalcemia risk in patients with advanced chronic kidney disease; the communication specifically discusses dialysis patients and people with CKD-mineral and bone disorder. This is U.S. regulatory information for a named product and population. It cannot determine whether any person is in that population, needs testing or monitoring, or should start, defer, stop or change a product. Check the current target-market label, actual product and responsible care team.
Open the official source record ↗reviewed 2026-08-22Amoxil · amoxicillinOpen the matching dossier and check the product in hand against its current public label
FDA FAERS record: labelling-update information for amoxicillin-related products
FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Amoxil and several amoxicillin-containing products and states that Warnings and Precautions and Adverse Reactions were updated in May 2024 with drug-induced enterocolitis syndrome (DIES) information. This is an FDA safety-signal and labelling-update record; it does not diagnose symptoms or replace the exact product’s current target-market label and professional review.
Open the official source record ↗reviewed 2026-08-22Jardiance · 恩格列净; Farxiga · 达格列净Open the matching dossier and check the product in hand against its current public label
FDA FAERS record: SGLT2-inhibitor labelling-update information
FDA’s July–September 2023 potential-signal/new-safety-information table, displayed as current through 2026-03-13, lists Jardiance (empagliflozin) and Farxiga (dapagliflozin) among SGLT2 inhibitors and says their Warnings and Precautions labelling was updated in September 2023 to include prolonged diabetic ketoacidosis and glucosuria information. This is a regulatory safety-signal and labelling-update record; it cannot determine an individual event or support self-stopping, switching or changing treatment.
Open the official source record ↗reviewed 2026-08-22Bactrim · sulfamethoxazole and trimethoprimOpen the matching dossier and check the product in hand against its current public label
FDA FAERS record: labelling-update information for sulfamethoxazole/trimethoprim
FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Bactrim, Bactrim DS and related sulfamethoxazole/trimethoprim products and states that Warnings and Precautions and Adverse Reactions were updated in February 2025 with hemophagocytic lymphohistiocytosis (HLH) information. It is a regulatory safety-signal and labelling-update record, not a way to determine an individual event or self-stop/switch treatment.
Open the official source record ↗reviewed 2026-08-22Lipitor · 阿托伐他汀Open the matching dossier and check the product in hand against its current public label
EMA PRAC product-information signal: statins including Lipitor (atorvastatin) and myasthenia gravis / ocular myasthenia
In its product-information wording extract dated 2023-02-06, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) includes Lipitor (atorvastatin) within the statin class. The document says that, in a few reported cases, statins may induce new-onset or aggravate pre-existing myasthenia gravis or ocular myasthenia, and that recurrence after re-administration of the same or a different statin has been reported. This is a dated EU product-information signal; it does not mean that any Lipitor pack, another market, or any individual has this problem, and it does not support self-stopping, switching, reducing, increasing, or alternating treatment. New or worsening muscle-weakness questions need the actual pack and complete medicine list reviewed promptly by the prescribing team or pharmacist; emergencies require local emergency services.
Open the official source record ↗reviewed 2026-08-22CRESTOR · 瑞舒伐他汀钙Open the matching dossier and check the product in hand against its current public label
EMA PRAC product-information signal: statins including Crestor (rosuvastatin) and myasthenia gravis / ocular myasthenia
In its product-information wording extract dated 2023-02-06, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) includes Crestor (rosuvastatin) within the statin class. The document says that, in a few reported cases, statins may induce new-onset or aggravate pre-existing myasthenia gravis or ocular myasthenia, and that recurrence after re-administration of the same or a different statin has been reported. This is a dated EU product-information signal; it does not mean that any Crestor pack, another market, or any individual has this problem, and it does not support self-stopping, switching, reducing, increasing, or alternating treatment. New or worsening muscle-weakness questions need the actual pack and complete medicine list reviewed promptly by the prescribing team or pharmacist; emergencies require local emergency services.
Open the official source record ↗reviewed 2026-08-22Lipitor · 阿托伐他汀; CRESTOR · 瑞舒伐他汀钙; Zocor · simvastatinOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: labelling changes for statins in pregnancy and breastfeeding
On 2021-07-20, FDA issued a class Drug Safety Communication that explicitly lists Lipitor (atorvastatin) and Crestor (rosuvastatin). It concerns U.S. prescribing-information changes around pregnancy and breastfeeding and individualized benefit-risk review; it does not support self-starting, stopping, switching or adjusting any individual medicine. Pregnancy, suspected pregnancy or breastfeeding questions require the exact product, current target-market label and the prescribing team.
Open the official source record ↗reviewed 2026-08-22Celebrex · celecoxibOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: NSAID risk communication in pregnancy at about 20 weeks or later, including celecoxib
On 2020-10-15, FDA issued an NSAID Drug Safety Communication whose product table explicitly lists celecoxib/Celebrex. It says NSAID use at about 20 weeks of pregnancy or later may be associated with fetal kidney problems and low amniotic fluid, and describes related U.S. prescribing-information updates. This is a dated U.S. class regulatory communication; it does not establish that any person has a problem or support self-starting, stopping, switching, reducing, or replacing pain medicine. Pregnancy, suspected pregnancy, or pain-medicine questions require review of the exact product, current label for the relevant market, and complete medicine list with the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Advil · ADVIL TABLETSOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: NSAID risk communication in pregnancy at about 20 weeks or later, including ibuprofen
On 2020-10-15, FDA issued an NSAID Drug Safety Communication that explicitly names ibuprofen and says the risk communication applies to prescription and over-the-counter NSAIDs: use at about 20 weeks of pregnancy or later may be associated with fetal kidney problems and low amniotic fluid. The Advil dossier links this dated U.S. class communication through ibuprofen as its active-ingredient clue. It does not mean that any Advil pack, another ibuprofen product, another market or any individual has a problem, and it does not support self-starting, stopping, switching, changing an amount or replacing pain medicine. Pregnancy, suspected pregnancy, pain or fever questions require review of the exact product, current target-market label and complete medicine list with the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Xanax · 阿普唑仑Open the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: Boxed Warning update for benzodiazepines including alprazolam/Xanax
On 2020-09-23, FDA issued a benzodiazepine Drug Safety Communication whose product table explicitly lists alprazolam/Xanax and Xanax XR. It required updated U.S. Boxed Warnings to describe risks of abuse, misuse, addiction, physical dependence and withdrawal reactions consistently, and notes that use with opioids, alcohol or other central-nervous-system depressants can increase serious risks. This is a dated U.S. class regulatory communication; it cannot determine whether a person has dependence or an interaction, or support self-directed abrupt stopping, dose changes, alternating, combining with another sedating product or substitution. Put all prescriptions, non-prescription medicines, alcohol and other substances on one list for the prescribing team or pharmacist to review; trouble breathing, seizures or other severe symptoms require immediate local emergency support.
Open the official source record ↗reviewed 2026-08-22Singulair · montelukastOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: Boxed Warning for mental-health effects with montelukast (Singulair)
On 2020-03-04, FDA issued a Drug Safety Communication saying that, after reviewing available information, it required a Boxed Warning in prescribing information for montelukast (Singulair and generics) about mental-health effects and a new patient Medication Guide; the communication also describes U.S. benefit-risk considerations for allergic rhinitis. This is a dated U.S. regulatory communication, not a conclusion about any person’s symptoms, indication or current treatment. New or worsening mood, behavior or self-harm thoughts require prompt local emergency or clinical support; do not self-start, stop, switch or adjust a medicine from this card alone.
Open the official source record ↗reviewed 2026-08-22Lyrica · pregabalinOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: serious breathing-problem warning for gabapentinoids including Lyrica (pregabalin)
On 2019-12-19, FDA issued a Drug Safety Communication that explicitly lists Lyrica (pregabalin) and says serious breathing difficulties may occur with gabapentinoids in people with respiratory risk factors. The communication names use with opioid pain medicines or other central-nervous-system depressants, conditions that reduce lung function, and older age as context; FDA required respiratory-depression warnings in U.S. gabapentinoid prescribing information. This is a dated U.S. class regulatory communication. It does not mean that any Lyrica pack, another dosage form or market, any combination, or any individual has a problem, and it does not support self-stopping, reducing, increasing, switching, or independently adding/splitting Lyrica with another sedating medicine. Trouble breathing, unusual unresponsiveness, inability to wake, or another emergency requires local emergency services; non-emergency combination or risk questions need the actual pack and complete medicine list reviewed by a pharmacist or prescribing team.
Open the official source record ↗reviewed 2026-08-22Neurontin · gabapentinOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: serious breathing-problem warning for gabapentinoids including Neurontin (gabapentin)
On 2019-12-19, FDA issued a Drug Safety Communication that explicitly lists Neurontin (gabapentin) and says serious breathing difficulties may occur with gabapentinoids in people with respiratory risk factors. The communication names use with opioid pain medicines or other central-nervous-system depressants, conditions that reduce lung function, and older age as context; FDA required respiratory-depression warnings in U.S. gabapentinoid prescribing information. This is a dated U.S. class regulatory communication. It does not mean that any Neurontin pack, another dosage form or market, any combination, or any individual has a problem, and it does not support self-stopping, reducing, increasing, switching, or independently adding/splitting Neurontin with another sedating medicine. Trouble breathing, unusual unresponsiveness, inability to wake, or another emergency requires local emergency services; non-emergency combination or risk questions need the actual pack and complete medicine list reviewed by a pharmacist or prescribing team.
Open the official source record ↗reviewed 2026-08-22BIAXIN · Biaxin FilmtabOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: potential long-term risk with clarithromycin (BIAXIN) in patients with heart disease
On 22 Feb 2018, FDA issued a Drug Safety Communication advising careful benefit-risk review before prescribing clarithromycin (BIAXIN) to patients with heart disease because long-term follow-up data suggested a potential increase in heart problems or death years after treatment. This is a dated U.S. regulatory communication for a named population context. It does not mean every user will have a problem and does not support self-stopping an antibacterial or heart medicine or switching to another antibacterial. Chest pain, marked breathing difficulty, one-sided weakness or slurred speech requires immediate local emergency care; non-emergency co-use or substitution questions require the actual pack and complete medicine list to be reviewed by the prescribing team or pharmacist.
Open the official source record ↗Current regulatory record · reviewed 2026-09-02Glucophage · 二甲双胍Open the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: labelling update for metformin-containing medicines in reduced kidney function
On 2016-04-08, FDA issued a U.S. labelling update for all metformin-containing medicines. After its review, FDA changed the kidney-function measure used in labelling to eGFR and expanded labelled use for some people with mild or moderate renal impairment. This is a U.S. ingredient-level regulatory labelling change. It does not determine whether GLUCOPHAGE, an extended-release form, a product in another market, or any individual is suitable or unsuitable, and it does not support self-starting, stopping, reducing, increasing, or exchanging immediate-release and extended-release products. Kidney function, dosage form and co-medication questions require the exact product, current target-market label and review by the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Plavix · Clopidogrel Bisulfate TabletsOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: review of mortality risk with long-term Plavix/clopidogrel treatment
In a U.S. Drug Safety Communication issued on 2015-11-06, FDA said its review of the DAPT trial and other long-term clinical trials did not show that clopidogrel increases or decreases overall risk of death in people with, or at risk for, heart disease, and did not suggest increased cancer or cancer-death risk. The communication concerns evidence for long-term antiplatelet treatment in a specific U.S. trial context. It cannot determine an individual’s bleeding, clotting, cancer, treatment duration, need for genetic testing or co-medication plan, and it does not support self-stopping Plavix/clopidogrel or self-alternating, adding or replacing it with aspirin, anticoagulants, pain medicines or another product. Bleeding, chest pain, neurological symptoms or another acute concern needs local emergency support and review of the complete medicine list with the prescribing team or pharmacist.
Open the official source record ↗reviewed 2026-08-22Cipro · 环丙沙星; Levaquin · CRAVIT; Avelox · moxifloxacinOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones
On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list.
Open the official source record ↗reviewed 2026-08-22Prilosec OTC · PrilosecOpen the matching dossier and check the product in hand against its current public label
FDA Drug Safety Communication: C. difficile-associated diarrhoea communication for PPIs including Prilosec OTC
On 2012-02-08, FDA issued a class Drug Safety Communication saying that proton-pump inhibitors (PPIs), a group of stomach-acid medicines, may be associated with increased risk of Clostridioides difficile-associated diarrhoea (CDAD). FDA’s current OTC heartburn page lists Prilosec OTC (omeprazole magnesium) as a PPI and links this communication. This is a dated U.S. class communication: it cannot diagnose a cause of diarrhoea, determine individual risk for PRILOSEC OTC 20 mg delayed-release tablets, prescription omeprazole, another PPI or another market, or support self-stopping, dose changes, extending a course or switching acid-reducing medicines. Diarrhoea that does not improve or another acute concern needs prompt local medical support and review of the actual pack, complete medicine list and current label with a pharmacist or prescribing team.
Open the official source record ↗reviewed 2026-08-22Levaquin · CRAVITOpen the matching dossier and check the product in hand against its current public label
WHO historical quality alert: specific LEVAQUIN injection batches and unauthorised-channel risk
This notice concerns only two named 2006 batches of LEVAQUIN (levofloxacin) injection 25 mg/mL in 20 mL vials and their unauthorised distribution/storage risk. It does not apply to this dossier’s oral tablets, Japanese CRAVIT, or any current product-status conclusion.
Open the official source record ↗Historical public record · reviewed 2026-08-22
FOUR CHECKS
When you see a safety headline or have a concern, check in this order
Read the current target-market label
Open the public label or regulator product record linked from the relevant medicine dossier and confirm the document version.
Open the official safety notice
Check that the notice actually concerns that medicine, form and market, then read its date and regulatory action.
Bring the full context for help
Bring the real pack, symptom timeline and complete medicine list to a pharmacist, prescribing team or local health service; a webpage does not replace individual care.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services immediately. Do not wait for a website, search result or email reply.
REVIEWED OFFICIAL GATEWAYS · 22 AUGUST 2026
Global official pharmacovigilance gateways
These are reviewed regulator-level routes. They are not alerts about a particular medicine and they do not automatically match every dossier. Each medicine dossier also links to its own public label or product-record route.
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22