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Class III: unlikely to cause harmTerminated

Heritage Pharmaceuticals Acyclovir Tablets Recall

Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceutic…

Heritage Pharmaceuticals Inc · East Brunswick, NJ

Risk level
Class III
Reported by FDA
May 12, 2021
Recall ID
D-0367-2021
Check your lot numberHow we source this data

Summary

Heritage Pharmaceuticals recalled Acyclovir Tablets starting Apr 21, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0367-2021 on May 12, 2021. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date

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

Lot numbers, UPCs & expiration codes

Lot A120036, Exp DEC 2023

Where it was sold

OH

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0367-2021
Classification
Class III
Status
Terminated
Recall initiated
Apr 21, 2021
FDA report date
May 12, 2021
Quantity
408 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Heritage Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0367-2021, exactly as published.

Show all FDA fields
City
East Brunswick
State
NJ
Status
Terminated
Country
United States
Event ID
87762
Address
1 Tower Center Blvd Ste 1700
Code information
Lot A120036, Exp DEC 2023
Postal code
08816-1145
Report date
May 12, 2021
Product type
Drugs
Recall number
D-0367-2021
Classification
Class III
Recalling firm
Heritage Pharmaceuticals Inc
Product quantity
408 bottles
Termination date
Jun 9, 2022
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
OH
Recall initiation date
Apr 21, 2021
Initial firm notification
Letter
Center classification date
May 6, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0367-2021, published May 12, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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