Akorn Recalls Desoximetasone Gel Due to Impurity Specification Failure
Akorn, Inc. is recalling Desoximetasone Gel USP, 0.05%, because the product failed impurity specifications at the 9-month stability time point.
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 agency classification is FDA Class III, which the rubric defines as unlikely to cause adverse health consequences, corresponding to a Low severity score.
Plain-English summary
Akorn, Inc. is recalling Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes. The product is marketed by VersaPharm Incorporated and manufactured by Ei LLC. The recall involves 4,045 units with Lot number 1967800 and an expiration date of 10/2016.
The recall was initiated because the product was out of specification for an unknown impurity at the 9-month stability time point. The distribution pattern for the affected units is nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The product is prescription-only.
The recalled product
- Product
- Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 4,045
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#: 1967800
- Exp10/2016
Distribution
Distributed nationwide across the United States.
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