Akorn Recalls Desoximetasone Ointment for Stability Failures
Akorn Inc. is recalling Desoximetasone Ointment USP, 0.25%, due to failed stability specifications and phase separation.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II, and the hazard involves stability failures (phase separation) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Akorn Inc. is recalling Desoximetasone Ointment USP, 0.25%, in 15 g and 60 g tubes. The product is marketed by Versapharm Inc., an Akorn company, and manufactured by Hi-Tech Pharmacal Co., Inc. The recall involves Lot #348716, which has an expiration date of 12/2017.
The recall was initiated because the product failed stability specifications, specifically showing an out-of-specification value for homogeneity and phase separation. A total of 62 tubes of the 15 g size and 91 tubes of the 60 g size are affected. The product was distributed nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
- Manufacturer
- Akorn Inc
- Category
- Drug — Topical Steroid
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 (1)
- Lot #348716 (exp. 12/2017)
Distribution
Distributed nationwide across the United States.
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