FDA recall D-0134-2020

Amneal Pharmaceuticals, Inc. · Class III · drug

Product

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

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

Key facts

Status
Terminated
Initiation date
2019-09-24
Report date
2019-10-16
Termination date
2021-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0134-2020