Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles.
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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