D-0501-2023 Class II Terminated
FDA drug recall D-0501-2023 was initiated by RemedyRepack Inc. on March 20, 2023 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated October 19, 2023). Affected quantity: a) 399 bottles, b)445 bottles.
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
- a) 399 bottles, b)445 bottles
Product Description
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Reason for Recall
cGMP Deviations
Distribution Pattern
RemedyRepack distributed product to consignees nationwide within the United States
Code Information
Lot#: a) NDC 70518-0375-03: J0674788-011123, Exp. Date 01/31/2024; J0664118-112922 J0664118-112922, Exp. Date 12/31/2023; J0653727-101722, Exp. Date 10/31/2023. NDC 70518-0375-01: B2057931-011223, Exp. Date 07/31/2025 b) Lot #: B2075815-012523, Exp. Date 09/30/2025; B2011634-121322, Exp. Date 07/31/2025 B1970205-112022, Exp. Date 06/30/2024; B1862598-092022, Exp. Date 03/31/2024; B2077226-012523, B2070444-012023, Exp. Date 07/31/2025.