The Recall Desk
ModerateFDA (Drugs)·D-298-2013·Announced 2013-05-01

Qualitest Recalls Glimepiride Tablets Due to Oversized Tablet Finding

Qualitest Pharmaceuticals is recalling 10,373 bottles of Glimepiride 2 mg tablets because one oversized tablet was found in a sealed bottle at the retail level.

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: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific injuries or hospitalizations are reported in the source text, and the hazard is a physical specification failure rather than a high-risk pathogen or allergen.

Plain-English summary

Qualitest Pharmaceuticals is voluntarily recalling 10,373 bottles of Glimepiride Tablets USP, 2 mg, 100-count. The recall was initiated after one oversized tablet was discovered in a sealed 100-count bottle at the retail level. The affected product is identified by Lot # C0671212A and an expiration date of 12/14.

The product was distributed nationwide. Glimepiride is a prescription medication used to treat type 2 diabetes. The recall is classified as FDA Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers with this product should contact their pharmacist or healthcare provider for guidance on how to dispose of the medication or obtain a replacement. The recall number is D-298-2013.

The recalled product

Product
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
10,373

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 (2)

  • Lot #: C0671212A
  • Exp 12/14

Distribution

Distributed nationwide across the United States.

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