New Delhi : Zydus Cadila is recalling over 14,800 bottles of Bromocriptine Mesylate capsules manufactured by Cadila Healthcare on account of out of specification results in the US market.
According to information available on the United States Food and Drug Administration (USFDA) site, Zydus Pharmaceuticals USA Inc is recalling drugs manufactured by the Ahmedabad based Cadila Healthcare.
14,808 bottles of Bromocriptine Mesylate Capsules USP, 5 mg are being recalled on account of “Out of specification results noticed in related substance test during analysis of 24 month long-term (25 degree Celsius /65 pc RH) stability samples of two batches,” the latest enforcement report of the USFDA said.
The ongoing voluntary US nation wide recall is class II recall, it added.
As per the 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.”