Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurity Failures
Lupin Pharmaceuticals is recalling 2,712 bottles of Fluocinolone Acetonide Topical Solution because stability testing showed total impurities exceeded specifications.
What this means for you
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 due to failed impurity specifications, which the rubric categorizes as a moderate risk involving potential temporary or reversible health consequences without reported serious injury or death.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 2,712 60-ml bottles of Fluocinolone Acetonide Topical Solution, USP 0.01%. The product was manufactured by Novel Laboratories, Inc. and distributed nationwide in the USA. The specific lot affected is M16666, with an expiration date of 12/2018.
The recall was initiated because stability analysis revealed an out-of-specification result for total impurities. This indicates that the product failed to meet the required quality standards for impurity levels during its shelf life.
Consumers and healthcare providers should discontinue use of the affected product and return it to the pharmacy or point of purchase. The FDA has classified this as a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- LUPIN SOMERSET
- Category
- Drug — Topical Corticosteroid
- Hazard
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# M16666
- EXP 12/2018
UPCs (1)
- 0343386069606
Distribution
Distributed nationwide across the United States.
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