FDAFDA · Food and drugs·Recall number D-0501-2023
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.
Published April 12, 2023 · Recall initiated: March 20, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- RemedyRepack distributed product to consignees nationwide within the United States
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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