Drug recall D-0495-2023

Class II Terminated reported Apr 12, 2023

Product

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.

Reason for recall

cGMP Deviations

Lots and codes

Lot #: J0668398-121422, Exp. Date 12/31/2023; J0661225-111522, J0654053-101822 Exp. Date 11/30/2023; J0646383-091422, Exp. Date 09/30/2023

Recall details

Recalling firm
RemedyRepack Inc., Indiana, PA
Quantity
399 bottles
Distribution
RemedyRepack distributed product to consignees nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
March 20, 2023
Terminated
October 19, 2023