The Recall Desk
ModerateFDA (Drugs)·D-0559-2023·Announced 2023-05-10

Drug Recall: Glimepiride 4 mg for Manufacturing Practice Deviations

PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.

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 without reported illnesses or injuries. Voluntary precautionary recall initiated by the manufacturer due to manufacturing process deviations. Meets the rubric criteria for moderate-severity quality control issues without reported harm.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 186 bottles of Glimepiride USP 4 mg tablets that were distributed nationwide in the United States. The affected product is packaged at the company's Oklahoma City, Oklahoma facility and carries NDC number 43063-0587-90.

The FDA determined that the manufacturer had deviations from Current Good Manufacturing Practices (CGMP) standards during production. The company voluntarily initiated the recall on April 6, 2023. The recall was terminated on April 30, 2024.

Patients taking Glimepiride should consult their healthcare provider to determine whether their medication is from one of the affected lots and to discuss any needed alternatives. Specific lot numbers and expiration dates are available through the FDA recall notice. The affected lots have expiration dates ranging from January 2024 to June 2025.

The recalled product

Product
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug
Hazard
Affected units
186

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 (12)

  • Lots: A22B45 Exp. 01/31/24
  • C22A73
  • E22E41
  • C22D28
  • F22B68
  • G22A29
  • H22B97
  • K22A36 Exp. 03/31/24
  • K22B99
  • A23D07
  • B23B25 Exp. 10/31/24
  • B23B55 Exp. 06/30/25

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by PD-Rx Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · PD-Rx Pharmaceuticals, Inc.

See all →

Same hazard · manufacturing defect

See all →