Drug product
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
D-0812-2021
Product summary
- Event
- Event 88639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,820 bottles
- Official record key
drug-enforcement:D-0812-2021
Official wording
Reason: Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Code information: Lot: MJ1019025-A, Exp. date 04/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance