February 01, 2019
Lupin Somerset is recalling more than 24,000 bottles of fluocinolone acetonide topical solution USP, 0.01% because of impurities, according to the January 30, 2019, US Food and Drug Administration (FDA) Enforcement Report. Specifically, samples tested out of specification for total impurities, which were chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
The recall affects 60-mL bottles (NDC 43386-069-60) manufactured for Lupin Pharmaceuticals by Novel Laboratories Inc. from the following lots: S700214 (Exp. 4/19), S700447 (Exp. 6/19), S700787 (Exp. 10/19), S701057 (Exp. 11/19), S800107 (Exp. 2/20), S800266 (Exp. 3/20), S800524 (Exp. 5/20), and S800791 (Exp. 7/20). The affected bottles were distributed throughout the United States and in Puerto Rico.
Lupin Somerset voluntarily initiated the recall January 15, 2019. On January 23, 2019, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Fluocinolone acetonide topical solution is a prescription steroid used to treat eczema, rash, dermatitis, and other skin conditions.
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