Drug recall D-0085-2022

Class II Terminated reported Nov 10, 2021

Product

Dr. 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 43598-743-05

Reason for recall

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

Lots and codes

L100208, exp 01/2023

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
696 bottles
Distribution
Nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
October 5, 2021
Terminated
February 16, 2023

Related products