D-1272-2019 Class II Terminated
FDA drug recall D-1272-2019 was initiated by Zydus Pharmaceuticals USA Inc on April 25, 2019 and is designated Class II. 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 The recall status is terminated (terminated June 29, 2021). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2019
- Initiation Date
- April 25, 2019
- Termination Date
- June 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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
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
Distribution Pattern
Nationwide
Code Information
Z804517, Nov 30, 2020