Recall Enforment Report D-0082-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 10-05-2021 for the product Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) 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 The product was recalled due to failed excipient specifications; product manufactured using an excipient found to be oos for conductivity. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0082-202210-05-202111-10-2021Class IIa) 30,839 bottles, b) 3,830 bottlesDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) 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 USAFailed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivityOngoing
D-0081-202210-05-202111-10-2021Class IIa) 776 bottles, b) 84 bottlesDr. 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.Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivityOngoing
D-0084-202210-05-202111-10-2021Class IIa) 11,590 bottles b) 3,585 bottlesDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) 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 USAFailed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivityOngoing
D-0085-202210-05-202111-10-2021Class II696 bottlesDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count 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 NDC 43598-743-05Failed 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-0083-202210-05-202111-10-2021Class IIa) 3,444 bottles b) 469 bottles c) 142 bottlesDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) 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 USAFailed Excipient Specifications; 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
43598-742Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralDr.reddys Laboratories IncHuman Prescription Drug
43598-743Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralDr.reddys Laboratories IncHuman Prescription Drug
43598-744Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralDr.reddys Laboratories IncHuman Prescription Drug
43598-745Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralDr.reddys Laboratories IncHuman Prescription Drug