D-0495-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 20, 2023
- Termination Date
- October 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 399 bottles
Product Description
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
Reason for Recall
cGMP Deviations
Distribution Pattern
RemedyRepack distributed product to consignees nationwide within the United States
Code Information
Lot #: J0668398-121422, Exp. Date 12/31/2023; J0661225-111522, J0654053-101822 Exp. Date 11/30/2023; J0646383-091422, Exp. Date 09/30/2023