The Recall Desk
ModerateFDA (Drugs)·D-0493-2023·Announced 2023-04-12

Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations

RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for manufacturing quality deviations without documented adverse health events in the source. The hazard is manufacturing process-related rather than a specific product defect or contamination.

Plain-English summary

RemedyRepack Inc. has recalled Glimepiride 2 mg tablets in 30-count bottles (NDC 70518-0405-03), 90-count bottles (NDC 70518-0405-00), and 180-count bottles (NDC 70518-0405-02) due to cGMP (current Good Manufacturing Practice) deviations. A total of 220 bottles were distributed nationwide to consignees within the United States.

The firm voluntarily initiated the recall on March 20, 2023, and reported it to the FDA on April 12, 2023. The FDA classified it as a Class II recall. Multiple lot numbers are affected with expiration dates ranging from April 2023 through December 2024. Detailed lot numbers and expiration dates are available from the FDA.

The recall was terminated on October 19, 2023.

The recalled product

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
Manufacturer
RemedyRepack Inc.
Category
Drug — Antidiabetic
Hazard
  • manufacturing-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • B1692572-051822
  • Exp. Date 05/31/2023
  • B1803110-081122
  • Exp. Date 12/31/2024. c) B1820672-082422

Distribution

Distributed nationwide across the United States.

Related recalls

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