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 an 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.
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.