Drug 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
D-0227-2022
Product summary
- Event
- Event 88866
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 101 b) 145 bottles
- Official record key
drug-enforcement:D-0227-2022
Official wording
Reason: 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
Code information: a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Distribution pattern: Distributed to two distributors located in AZ and MO
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets