Benazepril Hydrochloride Tablet
FDA Recall NDC 65162-751
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Benazepril Hydrochloride (NDC 65162-751). A significant event, classified as Class III, was initiated on Sep 24, 2019 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2019 Class III Recall: Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Recall Number
Class III Terminated
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Sep 24, 2019
Oct 16, 2019
9,720 100 count bottles
Recall Profile & Regulatory Data
Event ID
83915
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
Termination Date
Mar 04, 2021
Product Description
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
Affected Packages Involved in this Recall
65162-751-03Product
65162-751-10Product
65162-751-50Product
65162-752-03Product
65162-752-10Product
65162-752-50Product
65162-753-03Product
65162-753-10Product
65162-753-50Product
65162-754-03Product
65162-754-10Product
65162-754-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
