Drug product
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
D-0362-2022
Product summary
- Event
- Event 89311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,684 1000-count bottles
- Official record key
drug-enforcement:D-0362-2022
Official wording
Reason: Complaint received of foreign matter (metal) embedded in tablet.
Code information: Batch # 210211H1, Exp. date FEB 2024
Distribution pattern: Product was distributed to one distributor who may have distributed the product further nationwide.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter