Drug recall
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals…
FDA recall event 83915 · Class III · Amneal Pharmaceuticals, Inc.
Key facts
| Event ID | 83915 |
|---|---|
| Recall numbers | D-0134-2020 |
| Recalling firm | Amneal Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle |
| Initiation date | Sep 24, 2019 |
| Report date | Oct 16, 2019 |
| Termination date | Mar 4, 2021 |
| City | Brookhaven |
| State | NY |
| Country | United States |
| FEI number | 3005263655 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: