The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0390-2019·Announced 2019-01-30

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.

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, 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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