Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: recalling drug products following an FDA inspection.
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
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.
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