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Class II: temporary or reversible health riskTerminated

Zydus Pharmaceuticals Acyclovir Tablets Recall

Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Heal…

Zydus Pharmaceuticals USA Inc · Pennington, NJ

Risk level
Class II
Reported by FDA
May 15, 2019
Recall ID
D-1272-2019
Check your lot numberHow we source this data

Summary

Zydus Pharmaceuticals recalled Acyclovir Tablets starting Apr 25, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1272-2019 on May 15, 2019. Reason: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg. Status: Terminated.

Why it was recalled

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

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

Lot numbers, UPCs & expiration codes

Z804517, Nov 30, 2020

Where it was sold

Nationwide

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-1272-2019
Classification
Class II
Status
Terminated
Recall initiated
Apr 25, 2019
FDA report date
May 15, 2019
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Zydus Pharmaceuticals USA Inc

Original FDA data

Every field from FDA enforcement report D-1272-2019, exactly as published.

Show all FDA fields
City
Pennington
State
NJ
Status
Terminated
Country
United States
Event ID
82714
Address
73 Route 31 N
Code information
Z804517, Nov 30, 2020
Postal code
08534-3601
Report date
May 15, 2019
Product type
Drugs
Recall number
D-1272-2019
Classification
Class II
Recalling firm
Zydus Pharmaceuticals USA Inc
Termination date
Jun 29, 2021
Reason for recall
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Apr 25, 2019
Initial firm notification
Letter
Center classification date
May 7, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1272-2019, published May 15, 2019. 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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