Lupin recalls from US over 24K bottles of Fluocinolone Acetonide topical solution
- Country:
- United States
Drug firm Lupin is recalling from the US and Puerto Rico over 24 thousand bottles of Fluocinolone Acetonide topical solution used for 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.
(With inputs from agencies.)
ALSO READ
Lupin, Glenmark recall drugs in US market: USFDA
USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant
Glenmark recalls 6,528 bottles of blood pressure drug in US
USFDA pulls up Natco Pharma for manufacturing lapses at Telangana plant
63,100 bottles of voting ink to be used in Kerala to prevent fraudulent voting during polls