Recalls / Class II
Class IID-0496-2023
Product
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
- Affected lot / code info
- Lot #: a) J0675206-011223, J0669260-121922, Exp. Date 01/31/2024; J0656820-103122, J0647161-091722, Exp. Date 09/30/2023 Exp. Date 11/30/2023; J0621491-052722, Exp. Date 06/30/2023; J0638138-080822, Exp. Date 08/31/2023, J0610887-041122, Exp. Date 04/30/2023. Lot # b) B1887315-100422, Exp. Date 02/28/2024; B1829906-083122, B1769715-071622, Exp. Date 09/30/2023; B1906605-101422, Exp. Date 02/28/2024; B1965118-111622, Exp. Date 02/28/2025.
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) 1,262 bottles, b) 95 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-0496-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.