Taro Recalls Subpotent Topicort Cream Tubes in Multiple States
Taro Pharmaceuticals is recalling 62,800 tubes of Topicort cream because the medication contained less active ingredient than labeled.
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 III, which indicates the product is not likely to cause adverse health consequences, but the subpotent nature of the drug represents a low-risk contamination or labeling error.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling 62,800 tubes of Topicort (desoximetasone) Cream USP, 0.05%. The product is packaged in 5 g tubes and is designated for professional sample use only. The recall was initiated because the medication was found to be subpotent, meaning it contained less of the active ingredient than stated on the label.
The affected product is identified by Lot # A5192-18338 and has an expiration date of 12/2016. The product was distributed in the United States, including California, Connecticut, Massachusetts, Maryland, New York, New Jersey, Oklahoma, Texas, and Washington. The recall was initiated on March 31, 2016, and the FDA classified it as Class III.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement. The recall status is currently terminated.
The recalled product
- Product
- ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-520
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 62,800
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 # A5192-18338
- Expiry: 12/2016
Distribution
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