Recall Enforment Report D-0227-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Golden State Medical Supply Inc., originally initiated on 10-14-2021 for the product Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05 The product was recalled due to failed excipient specifications and presence of foreign tablets/capsules; product manufactured using an excipient found to be oos for conductivity and some ezetimibe and simvastatin tablets, 10 mg/10 mg were found in the bottle. The product was distributed in Distributed To Two Distributors Located In Az And Mo and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0227-202210-14-202111-17-2021Class IIa) 101 b) 145 bottlesEzetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottleOngoing
D-0228-202210-14-202111-17-2021Class II49Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivityOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
51407-190Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGolden State Medical SupplyHuman Prescription Drug
51407-191Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGolden State Medical SupplyHuman Prescription Drug
51407-192Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGolden State Medical SupplyHuman Prescription Drug
51407-193Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGolden State Medical SupplyHuman Prescription Drug