Drug product
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
D-0427-2018
Product summary
- Event
- Event 79119
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7476 bottles
- Official record key
drug-enforcement:D-0427-2018
Official wording
Reason: Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Code information: Lot#: MTSC17145-A, Exp. July 2021
Distribution pattern: Nationwide within the US
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet