November 02, 2018
Lupin Somerset is recalling 2712 bottles of fluocinolone acetonide topical solution USP, 0.01%, according to the October 31, 2018, US Food and Drug Administration (FDA) Enforcement Report. During stability testing, an out-of-specification result occurred for impurities.
The recall affects 60-ml bottles (NDC 43386-069-60) manufactured for Lupin Pharmaceutical by Novel Laboratories. The recalled bottles are from lot M16666 (Exp. 12/18), which was distributed throughout the United States.
Lupin Somerset voluntarily initiated the recall October 5, 2018. On October 24, 2018, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. A remote possibility of serious harm also exists.
Fluocinolone acetonide topical solution is a prescription corticosteroid used to treat eczema, dermatitis, rash, and other skin conditions.
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