September 2019 FDA Recall Benazepril Hydrochloride by Amneal Pharmaceuticals, Inc.
D-0134-2020 - Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
This Class III drug recall was voluntarily initiated by Amneal Pharmaceuticals, Inc. on September 24, 2019 for the product Benazepril Hydrochloride. The FDA reported the reason for recall as presence of foreign tablet/capsule; promethazine hcl tablet found in the benazepril hcl bottle. The product was distributed in Product was distributed to 13 major distributors throughout the United States who may have further distribute the product. and the recall is currently terminated.
Recall Number: D-0134-2020
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
09-24-2019
10-16-2019
9,720 100 count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
03-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
Batch or Lot Expiration Information
Lot# BB02619A, exp. date 04/2021
