PlainRecalls
FDA Drug Moderate Class II Terminated

Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01

Reported: September 1, 2021 Initiated: August 17, 2021 #D-0754-2021

Product Description

Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01

Reason for Recall

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
4
Distribution
Product was distributed to two medical facilities in VA and FL.
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01. Recalled by RemedyRepack Inc.. Units affected: 4.
Why was this product recalled?
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 1, 2021. Severity: Moderate. Recall number: D-0754-2021.