The Recall Desk
LowFDA (Drugs)·D-1370-2015·Announced 2015-09-02

Taro Recalls Topicort Topical Spray Due to Impurity Test Failures

Taro Pharmaceuticals is recalling Topicort topical spray because impurity testing failed at 6 and 9 months. The recall covers 16,320 bottles distributed nationwide.

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 agency classified this as an FDA Class III recall, 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, Inc. is recalling 16,320 bottles of Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL. The affected product is a prescription-only medication manufactured in Brampton, Ontario, Canada, and distributed by TaroPharma in Hawthorne, NY. The recall covers two specific lots: C4177-14965 and C4178-14965, both with an expiry date of February 2016.

The recall was initiated due to failed impurities and degradation specifications. Out-of-specification results for impurities testing were obtained at the 6 and 9-month time points. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected product was distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiry dates listed above. Those who have used the product should contact their healthcare provider with any questions or concerns.

The recalled product

Product
TOPICORT (DESOXIMETASONE)
Brand
TOPICORT
Manufacturer
Taro Pharmaceuticals, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
16,320

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 #: C4177-14965
  • Expiry: February 2016
  • Lot #: C4178-14965
  • Expiry: February 2016.

Distribution

Distributed nationwide across the United States.

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