The Recall Desk
ModerateFDA (Drugs)·D-0527-2023·Announced 2023-04-12

Glimepiride Tablets Recall Due to Manufacturing Quality Deviations

Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.

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 initiated due to manufacturing quality deviations. No illnesses, injuries, or adverse events have been reported in the source material, and the hazard is administrative/preventive rather than based on documented patient harm.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Glimepiride Tablets USP, 4 mg manufactured by Accord Healthcare, Inc., Durham, NC. The recalled product consists of 15 bottles with lot numbers H1221Z, I0121J, and J0622X, with an expiration date of 10/31/2023. The affected medication was distributed nationwide in the United States.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations identified at Accord Healthcare following an FDA inspection. cGMP deviations indicate that manufacturing processes, quality controls, or facility standards did not meet federal requirements for drug production. The source documentation does not specify the particular nature of the deviations or whether any adverse effects have been reported in patients.

The recalled product

Product
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Antidiabetic medication
Hazard
Affected units
15

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 (4)

  • Lot: H1221Z
  • I0121J
  • J0622X
  • Exp 10/31/2023.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred 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 17 products in this recall →

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