Why it was recalled
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Product description
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
Lot numbers, UPCs & expiration codes
Lot # BB02619A, exp. date 04/2021
Where it was sold
Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0134-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 24, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 9,720 100 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0134-2020, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83915
- Address
- 50 Horseblock Rd
- Code information
- Lot # BB02619A, exp. date 04/2021
- Postal code
- 11719-9509
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0134-2020
- Classification
- Class III
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Product quantity
- 9,720 100 count bottles
- Termination date
- Mar 4, 2021
- Reason for recall
- Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
- Distribution pattern
- Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
- Recall initiation date
- Sep 24, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2019