D-0493-2023 Class II Terminated
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) 147 bottles, b)70 bottles, c) 3 bottles
Product Description
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
Reason for Recall
cGMP Deviations
Distribution Pattern
RemedyRepack distributed product to consignees nationwide within the United States
Code Information
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.