Atenolol Tablet
FDA Recall NDC 68382-024
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Atenolol (NDC 68382-024). A significant event, classified as Class II, was initiated on Mar 06, 2017 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet."
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
Class II Terminated
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Mar 06, 2017
Mar 29, 2017
9561 bottles
Recall Profile & Regulatory Data
Event ID
76673
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Nov 05, 2019
Product Description
ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.
Batch or Lot Expiration Information
Lot# : a) Z600724, Exp 04/18; Z600725, Exp 04/18
Affected Packages Involved in this Recall
68382-022-16Product
68382-022-01Product
68382-022-10Product
68382-022-40Product
68382-022-24Product
68382-023-16Product
68382-023-01Product
68382-023-10Product
68382-023-02Product
68382-023-40Product
68382-023-24Product
68382-024-16Product
68382-024-01Product
68382-024-10Product
68382-024-40Product
Class II Terminated
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Aug 05, 2014
Oct 15, 2014
5400 bottles
Recall Profile & Regulatory Data
Event ID
68988
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 22, 2017
Product Description
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
Batch or Lot Expiration Information
Lot# MP2292 Exp. 01/16
Affected Packages Involved in this Recall
68382-022-16Product
68382-022-01Product
68382-022-10Product
68382-022-40Product
68382-022-24Product
68382-023-16Product
68382-023-01Product
68382-023-10Product
68382-023-02Product
68382-023-40Product
68382-023-24Product
68382-024-16Product
68382-024-01Product
68382-024-10Product
68382-024-40Product
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.
