Teva Recalls Fluocinolone Acetonide Topical Solution for Impurity and Potency Issues
Teva Pharmaceuticals USA is recalling Fluocinolone Acetonide Topical Solution due to failed impurity and potency specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard involves subpotency and impurities, which are quality issues rather than acute toxic hazards, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Teva Pharmaceuticals USA is recalling 27,803 bottles of Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL. The product is a prescription topical corticosteroid manufactured by Actavis Laboratories UT, Inc. and distributed by Actavis Pharma, Inc. The recall covers specific lots with expiration dates ranging from October 2018 to January 2020.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, out-of-specification test results indicated that the drug was subpotent (below assay) and contained degradants above the allowed specification. This means the medication may not be effective and may contain unwanted chemical byproducts.
The affected product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions. The specific lot numbers involved are 1164898, 1164904, 1164909, 1211396, 1230808, and 1231127.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE TOPICAL (FLUOCINOLONE ACETONIDE TOPICAL)
- Brand
- FLUOCINOLONE ACETONIDE TOPICAL
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 27,803
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 (10)
- Lot #s: 1164898
- EXP 10/18
- 1164904
- 1164909
- EXP 11/18
- 1211396
- EXP 07/19
- 1230808
- 1231127
- EXP 01/20
Distribution
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