The Recall Desk
HighFDA (Drugs)·D-0393-2023·Announced 2023-03-08

Accord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations

Accord Healthcare is recalling Glimepiride 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. The recall affects 469,944 bottles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for manufacturing practice deviations with no reported adverse events or illnesses. While Class II recalls indicate a more serious condition than Class III, the absence of specific identified hazards or reported injuries places this at the High severity level per the rubric.

Plain-English summary

Accord Healthcare, Inc. is recalling Glimepiride tablets (USP, 1 mg) in response to Current Good Manufacturing Practice (CGMP) deviations identified during a U.S. Food and Drug Administration (FDA) inspection. The recall covers 469,944 bottles distributed throughout the United States, including Puerto Rico, and Canada.

The recalled product consists of two package sizes: 100-count bottles (NDC 16729-001-01) and 500-count bottles (NDC 16729-001-16). The tablets were manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, for Accord Healthcare, Inc. Multiple batches are affected, with expiration dates ranging from April 2023 through August 2025.

Glimepiride is a prescription medication used to treat Type 2 diabetes. The CGMP deviations identified in the manufacturing process prompted this recall. Consumers should contact their healthcare provider or pharmacist about whether they have been affected and what steps to take regarding their medication.

The recalled product

Product
GLIMEPIRIDE (GLIMEPIRIDE)
Brand
GLIMEPIRIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Antidiabetic medication
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)

  • Batches: a) R2000166
  • Exp. Date 4/30/2023
  • P2003528 Exp. Date 6/30/2023
  • P2005451 Exp. Date 8/31/2023
  • P2005438 Exp. Date 8/31/2023
  • P2005436 Exp. Date 8/31/2023
  • P2005437 Exp. Date 8/31/2023
  • P2005452 Exp. Date 8/31/2023
  • P2006055 Exp. Date 9/30/2023
  • P2101782 Exp. Date 2/28/2024
  • P2101783 Exp. Date 2/28/2024
  • P2101781 Exp. Date 2/29/2024
  • P2102171 Exp. Date 2/29/2024
  • P2101844 Exp. Date 3/31/2024
  • P2101846 Exp. Date 3/31/2024
  • P2101845 Exp. Date 3/31/2024
  • b) P2006510 Exp. Date 11/30/2023
  • P2100975 Exp. Date 1/31/2024
  • P2100625 Exp. Date 1/31/2024
  • P2101778 Exp. Date 2/29/2024

UPCs (4)

  • 0316729003018
  • 0316729002011
  • 316729001014
  • 316729001168

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · GLIMEPIRIDE

Same category