Drug product
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
D-0163-2017
Product summary
- Event
- Event 75698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1739 bottles
- Official record key
drug-enforcement:D-0163-2017
Official wording
Reason: Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Code information: Lot 6121056, exp 5/2019
Distribution pattern: AL, FL, GA, SC & TN
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets