Recalls / Class III
Class IIID-0134-2020
Product
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
- Brand name
- Benazepril Hydrochloride
- Generic name
- Benazepril Hydrochloride
- Active ingredient
- Benazepril Hydrochloride
- Route
- Oral
- NDCs
- 65162-751, 65162-752, 65162-753, 65162-754
- FDA application
- ANDA076820
- Affected lot / code info
- Lot # BB02619A, exp. date 04/2021
Why it was recalled
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Recalling firm
- Firm
- Amneal Pharmaceuticals, Inc.
- Manufacturer
- Amneal Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 9,720 100 count bottles
- Distribution pattern
- Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
Timeline
- Recall initiated
- 2019-09-24
- FDA classified
- 2019-10-09
- Posted by FDA
- 2019-10-16
- Terminated
- 2021-03-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0134-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.