New Delhi: Mumbai based drug firm Lupin is recalling from the US and Puerto Rico over 24 thousand bottles of Fluocinolone Acetonide topical solution used for the treatment of a variety of skin conditions.
According to a USFDA report, Lupin Somerset is recalling 24,180 bottles of Fluocinolone Acetonide topical solution USP, 0.01 per cent in 60 ml bottle, manufactured by Novel Laboratories Inc for US-based Lupin Pharmaceuticals Inc.
The reason for the recall is failed impurities/degradation specifications, it added.
The distribution pattern of the product was nationwide in the US and Puerto Rico, the report said.
The voluntary ongoing recall is a class II recall, it added.
According to USFDA, a class II recall is initiated in 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.
Fluocinolone Acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.