Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns
Fougera Pharmaceuticals is recalling 3,594 bottles of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.
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.
Plain-English summary
Fougera Pharmaceuticals Inc. is recalling 3,594 bottles of Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL. The affected product is identified by Lot 849R with an expiration date of 04/2015. The recall is classified as Class III by the FDA.
The recall was initiated because it has been determined that the pH of the recalled lots may not meet specification at expiry. This is a potential quality control issue regarding the product's chemical stability over time.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 3,594
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: 849R
- Exp 04/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fougera Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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