Acyclovir Tablet
FDA Recall NDC 68382-792
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 Acyclovir (NDC 68382-792). A significant event, classified as Class II, was initiated on Apr 25, 2019 by Zydus Pharmaceuticals (usa) Inc.. The reported reason for this action was: "Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg"
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
April 2019 Class II Recall: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Recall Number
Class II Terminated
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Apr 25, 2019
May 15, 2019
N/A
Recall Profile & Regulatory Data
Event ID
82714
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 29, 2021
Product Description
Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01
Batch or Lot Expiration Information
Lot# Z804517, Nov 30, 2020
Affected Packages Involved in this Recall
68382-791-06Product
68382-791-16Product
68382-791-01Product
68382-791-05Product
68382-791-10Product
68382-791-30Product
68382-792-06Product
68382-792-16Product
68382-792-01Product
68382-792-05Product
68382-792-10Product
68382-792-30Product
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.
