Lupin Recalls Desoximetasone Topical Spray Due to Impurity Failures
Lupin Pharmaceuticals is recalling 876 bottles of Desoximetasone Topical Spray because high out-of-specification impurities were detected.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when significant quality failures like high out-of-specification impurities are involved.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 876 bottles of Desoximetasone Topical Spray, 0.25%, 100 mL bottles. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals in Baltimore, MD.
The recall was initiated because the product failed impurities and degradation specifications, with high out-of-specification results observed. The affected lots are K800475 (expiration date May 2020) and K800477 (expiration date June 2020). The product was distributed throughout the United States.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 876
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)
- K800475 exp. date May 2020 K800477 exp. date June 2020
Distribution
Distribution scope not specified by the agency.
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