The Recall Desk
LowFDA (Drugs)·D-66402-001·Announced 2013-10-30

Tolmar Recalls Subpotent Ketoconazole Shampoo Nationwide

Tolmar Inc. is voluntarily recalling 391,055 bottles of 2% Ketoconazole Shampoo nationwide because the product was found to be subpotent.

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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for minor or theoretical risks.

Plain-English summary

Tolmar Inc. is voluntarily recalling 391,055 bottles of Ketoconazole Shampoo, 2%, manufactured in Fort Collins, Colorado, for Sandoz Inc. The recall was initiated on September 23, 2013, and the product was distributed nationwide. The recall was initiated because the shampoo was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the label.

The affected product is identified by NDC 0781-7090-04. The recall covers specific lots with expiration dates ranging from August 2013 to October 2014. The recall was classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences. The recall status is terminated as of April 10, 2014.

Consumers who have this product should stop using it and contact the manufacturer or their healthcare provider for further instructions. The recall was initiated by the firm and notified via letter.

The recalled product

Product
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Manufacturer
Tolmar, Inc.
Category
Drug — Topical Antifungal
Hazard
Affected units
391,055

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)

  • Lots: 6111A exp 8/14
  • 6191A exp 10/14
  • 5523A exp1/14
  • 5617A exp 2/14
  • 5619A exp2/14
  • 5660A exp 3/14
  • 5689A exp 3/14
  • 5690A exp 3/14
  • 6114A exp 9/14
  • 6115A exp 9/14
  • 6118A exp 9/14
  • 6122A exp 9/14
  • 5307A exp 8/13
  • 5391A exp 10/13
  • 5393A exp 10/13
  • 5392A exp 10/13
  • 5394A exp 10/13
  • 5396A exp 11/13
  • 5430A exp 11/13
  • 5431A exp 11/13

Distribution

Distributed nationwide across the United States.

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