Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Specification Failure
Akorn, Inc. is recalling 3,937 bottles of Triamcinolone Acetonide Lotion USP, 0.025% because a known impurity exceeded specifications at the 12-month stability point.
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 recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2. No illnesses or injuries are reported.
Plain-English summary
Akorn, Inc. is recalling 3,937 bottles of Triamcinolone Acetonide Lotion USP, 0.025% (NDC 61748-219-60). The affected product is supplied in 60 mL bottles and was distributed nationwide. The specific lots involved are 1413900, 1417200, and 1417300, all with an expiration date of 02/15.
The recall was initiated because a known impurity in the product went out of specification at the 12-month stability point. This is a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 3,937
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)
- Lots 1413900
- 1417200
- 1417300
- Exp. 02/15
Distribution
Distributed nationwide across the United States.
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