D-0134-2020 Class III Terminated
FDA drug recall D-0134-2020 was initiated by Amneal Pharmaceuticals, Inc. on September 24, 2019 and is designated Class III. Reason for recall: Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle The recall status is terminated (terminated March 4, 2021). Affected quantity: 9,720 100 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 16, 2019
- Initiation Date
- September 24, 2019
- Termination Date
- March 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,720 100 count bottles
Product Description
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
Reason for Recall
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Distribution Pattern
Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
Code Information
Lot # BB02619A, exp. date 04/2021