Fougera Recalls Triamcinolone Acetonide Cream Due to Labeling Error
Fougera Pharmaceuticals is recalling 493,192 tubes of Triamcinolone Acetonide Cream 0.1% because the end flap incorrectly displays 01% instead of 0.1%.
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 typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a minor labeling error.
Plain-English summary
Fougera Pharmaceuticals Inc. is recalling 493,192 tubes of Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube. The product is a prescription-only topical corticosteroid manufactured by E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., in Melville, New York.
The recall was initiated due to a labeling error on the product packaging. Specifically, there is a misprint on the end flap of the tube which reads "01%" rather than the correct declared strength of "0.1%". The affected lots include 485P, 486P, 487P, 488P (Exp 06/15); 638P, 639P, 640P (Exp 07/15); 753P, 754P, 755P (Exp 08/15); and 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P (Exp 09/15). The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
- Brand
- TRIAMCINOLONE ACETONIDE
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 493,192
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 (20)
- Lot #: 485P
- 486P
- 487P
- 488P
- Exp 06/15
- 638P
- 639P
- 640P
- Exp 07/15
- 753P
- 754P
- 755P
- Exp 08/15
- 898P
- 756P
- 757P
- 758P
- 899P
- 900P
- 901P
UPCs (4)
- 0301680004150
- 0301680003153
- 0301680002156
- 301680004808
Distribution
Distributed nationwide across the United States.
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