Drug product
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
D-0134-2020
Product summary
- Event
- Event 83915
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,720 100 count bottles
- Official record key
drug-enforcement:D-0134-2020
Official wording
Reason: Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Code information: Lot # BB02619A, exp. date 04/2021
Distribution pattern: Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet