Acyclovir Tablet
FDA Recall NDC 23155-228
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 23155-228). A significant event, classified as Class III, was initiated on Apr 21, 2021 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date"
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 III Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date
Apr 21, 2021
May 12, 2021
408 bottles
Recall Profile & Regulatory Data
Event ID
87762
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH
Termination Date
Jun 09, 2022
Product Description
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle
Batch or Lot Expiration Information
Lot# Lot A120036, Exp DEC 2023
Affected Packages Involved in this Recall
23155-227-01Product
23155-227-05Product
23155-228-01Product
23155-228-05Product
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.
