D-0754-2021 Class II Terminated
FDA drug recall D-0754-2021 was initiated by RemedyRepack Inc. on August 17, 2021 and is designated Class II. 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. The recall status is terminated (terminated March 9, 2022). Affected quantity: 4.
Recall Details
- Product Type
- Drugs
- Report Date
- September 1, 2021
- Initiation Date
- August 17, 2021
- Termination Date
- March 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
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.
Distribution Pattern
Product was distributed to two medical facilities in VA and FL.
Code Information
Lot # B1273286-071521, Exp 07/31/2022