Apotex Corp.
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, C
Reason Failed dissolution specifications.
Add to Desktop
Use Chrome or Edge for the best install experience.
Stay informed with the latest FDA drug recalls, safety alerts, and pharmacy insights from our clinical team.
Recent drug recall information from the FDA’s enforcement database.
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, C
Reason Failed dissolution specifications.
amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Te
Reason Discoloration: consumer complaints received for discolored tablets
FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Man
Reason Lack of Assurance of Sterility
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater
Reason Failed Dissolution Specifications: below specification
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with
Reason Lack of Assurance of Sterility
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5
Reason Lack of Assurance of Sterility
Practical health information from our licensed pharmacists.
Taking medication as directed can help it work as intended. A routine, pill organizer, or dose packaging may make a schedule easier to follow. Ask your pharmacist for help finding an approach that fits your day.
FDA-approved generic medicines have the same active ingredient, strength, dosage form, and route as their brand-name counterparts. Ask your pharmacist whether a generic option is appropriate for your prescription.
Seasonal vaccination can help reduce the risk of influenza. Handwashing, staying home when ill, and asking a healthcare professional about your personal risks are other useful steps.
Share prescription medicines, over-the-counter products, vitamins, and supplements with your care team. A current list helps your pharmacist review possible interactions and answer questions.
Storage needs vary by medicine. Follow the label or patient information, and keep medicines in their original containers unless your pharmacist recommends another option.
Check the label for directions and review the patient information that comes with your medicine. If a dose, timing, or possible side effect is unclear, ask your pharmacist or prescriber.
Reports submitted to the FDA help monitor medicine safety. A report alone does not establish that a medicine caused an event.
Incorrect dose administered
Brain natriuretic peptide increased, Cardiac failure
Blood potassium increased, Glaucoma, Blood creatinine abnormal, Glomerular filtration rate increased
Movement disorder, Myopathy, Myalgia
Warm autoimmune haemolytic anaemia
Pulmonary valve incompetence
FDA recall and adverse event information is provided for general education and awareness. FDA reports may be incomplete or change as information is reviewed; an adverse event report does not mean a medicine caused the event. This page is not medical advice and is not a substitute for advice from your physician or pharmacist. Do not change or stop a medication without talking with your care team.
Questions about a prescription, how it was made, or how to store it? A real person answers during weekday hours.
Contact our teamOr call (317) 293-1700 · Mon–Fri: 8am–5pm