The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-347-2014·Announced 2013-12-18

Taro Recalls Subpotent Ciclopirox Shampoo 1% Prescription Bottles

Taro Pharmaceuticals is recalling 850 bottles of Ciclopirox Shampoo 1% because the product is subpotent. The recall is voluntary and nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling 850 bottles of Ciclopirox Shampoo 1%, Net Wt. 120 mL. The product is a prescription-only topical medication manufactured by Taro Pharmaceuticals Inc. in Brampton, Ontario, Canada, and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, New York. The specific lot affected is H3135, with an expiration date of January 2015. The NDC for the product is 51672-1351-8.

The recall was initiated because the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the label. The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall was initiated on October 16, 2013, and was terminated on May 18, 2018.

The affected product was distributed nationwide. Consumers and healthcare providers who have this specific lot of Ciclopirox Shampoo should stop using it and contact their healthcare provider or pharmacist for guidance. The recall was initiated by the firm and involved notification via email, fax, letter, press release, telephone, or visit.

The recalled product

Product
CICLOPIROX (CICLOPIROX)
Brand
CICLOPIROX
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — Topical Antifungal
Hazard
Affected units
850

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 #: H3135
  • Exp. January 2015

UPCs (1)

  • 0351672135188

Distribution

Distributed nationwide across the United States.

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