Recall: D-0083-2022

Class II - Potentially Harmful

Class IIClassification

2021-10-05Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

Dr. 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 USA

Reason

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Distribution

Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.