Recall: D-0134-2020

Class III - Minor Violations

Class IIIClassification

2019-09-24Initiated

TerminatedStatus

Amneal Pharmaceuticals, Inc.Firm

Product

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

Reason

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

Distribution

Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.