PlainRecalls
FDA Drug Moderate Class II Terminated

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

Reported: May 15, 2019 Initiated: April 25, 2019 #D-1273-2019

Product Description

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

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

Details

Units Affected
3900
Distribution
Nationwide
Location
Pennington, NJ

Frequently Asked Questions

What product was recalled?
Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 3900.
Why was this product recalled?
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Which agency issued this recall?
This recall was issued by the FDA Drug on May 15, 2019. Severity: Moderate. Recall number: D-1273-2019.