The Recall Desk
LowFDA (Drugs)·D-1405-2015·Announced 2015-09-09

Qualitest Recalls Allopurinol Tablets Due to Oversized and Discolored Appearance

Qualitest Pharmaceuticals is recalling 21,552 bottles of 300 mg Allopurinol tablets because some tablets are oversized and discolored.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classifies this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is a cosmetic defect (discoloration/size) rather than a safety hazard.

Plain-English summary

Qualitest Pharmaceuticals is recalling 21,552 bottles of Allopurinol Tablets, USP, 300 mg, 500 count. The recall was initiated due to a report of tablets that are oversized and discolored, which constitutes a failure of tablet specifications.

The affected product is identified by NDC 0603-2116-28, Control Number CP0761501, and an expiration date of 12/16. The product was distributed nationwide and in Puerto Rico.

Consumers who have this product should contact their pharmacist or physician for a replacement or refund. The FDA classifies this recall as Class III, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product
ALLOPURINOL (ALLOPURINOL)
Brand
ALLOPURINOL
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Prescription Drug
Hazard
Affected units
21,552

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)

  • CP0761501
  • Exp. 12/16

UPCs (2)

  • 0306032115218
  • 0306032116215

Distribution

Distributed nationwide across the United States.

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