Recalls / Class II
Class IID-0493-2023
Product
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
- Affected lot / code info
- Lot #: a) J0674153-010923, Exp. Date 01/31/2024; J0649447-092822, Exp. Date 10/31/2023; J0644887-090722, Exp. Date 09/30/2023; J0627309-062222, Exp. Date 06/30/2023; J0622569-060222, Exp. Date 06/30/2023. b) B1646259-041222, Exp. Date 04/30/2023; B2032846-122722, Exp. Date 01/31/2025 B2018675-121722, Exp. Date 05/31/2025; B1708230-060122, B1709748-060122, Exp. Date 06/30/2023; B1692572-051822, Exp. Date 05/31/2023; B1803110-081122, Exp. Date 12/31/2024. c) B1820672-082422, B1814883-082022, Exp. Date 09/30/2024.
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) 147 bottles, b)70 bottles, c) 3 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-0493-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.