Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of foreign substance: metallic razor blade was found in one bottle.
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP deviations.
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.