Recalls / Class II
Class IID-0501-2023
Product
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.
- Affected lot / code info
- 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.
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- a) 399 bottles, b)445 bottles
- Distribution pattern
- RemedyRepack distributed product to consignees nationwide within the United States
Timeline
- Recall initiated
- 2023-03-20
- FDA classified
- 2023-03-31
- Posted by FDA
- 2023-04-12
- Terminated
- 2023-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0501-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.