FDA Drug Low Class III Terminated

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

Reported: October 16, 2019 Initiated: September 24, 2019 #D-0134-2020

Product Description

Reason for Recall

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Details

Recalling Firm: Amneal Pharmaceuticals, Inc.
Units Affected: 9,720 100 count bottles
Distribution: Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
Location: Brookhaven, NY

Frequently Asked Questions

What product was recalled? ▼

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10. Recalled by Amneal Pharmaceuticals, Inc.. Units affected: 9,720 100 count bottles.

Why was this product recalled? ▼

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on October 16, 2019. Severity: Low. Recall number: D-0134-2020.