April 2021 FDA Recall Acyclovir by Heritage Pharmaceuticals Inc
D-0367-2021 - Labeling

This Class III drug recall was voluntarily initiated by Heritage Pharmaceuticals Inc on April 21, 2021 for the product Acyclovir. The FDA reported the reason for recall as labeling. The product was distributed in OH and the recall is currently terminated.

Recall Number: D-0367-2021

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Initiated
04-21-2021
Reported
05-12-2021
Quantity
408 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87762
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Heritage Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-09-2022
Product Description About Product Description
Full technical description of the product.
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

23155-227-01 Acyclovir
23155-227-05 Acyclovir
23155-228-01 Acyclovir
23155-228-05 Acyclovir