Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities
Lupin Pharmaceuticals is recalling 24,180 bottles of Fluocinolone Acetonide Topical Solution due to elevated impurities.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 24,180 bottles of Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL. The product is a prescription-only topical corticosteroid manufactured by Novel Laboratories, Inc. The recall is an expansion of a previous recall from October 2018.
The recall was initiated because of elevated out-of-specification results for total impurities. These impurities have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient. The affected lots include S700214, S700447, S700787, S701057, S800107, S800266, S800524, and S800791, with expiration dates ranging from April 2019 to July 2020.
The product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- LUPIN SOMERSET
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 24,180
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 (16)
- Lot #: S700214
- Exp Apr-19
- S700447
- Exp Jun-19
- S700787
- Exp Oct-19
- S701057
- Exp Nov-19
- S800107
- Exp Feb-20
- S800266
- Exp Mar-20
- S800524
- Exp May-20
- S800791
- Exp Jul-20
UPCs (1)
- 0343386069606
Distribution
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