Zydus Issues Voluntary Recall of Promethazine TabletsBy
Zydus Pharmaceuticals USA Inc., part of the the pharmaceutical company Zydus Cadila, has issued a voluntary Class II recall of 10,200 bottles of promethazine hydrochloride tablets, USP, 25 mg, 100 prescription only, due to the presence of atenolol 25-mg tablet mixed into promethazine 25-mg tablet bottles.
The nationwide voluntary recall was initiated on May 8, 2014, according to the FDA’s weekly enforcement report of May 28, 2014. The tablets were manufactured by Cadila Healthcared Ltd., India and distributed by Zydus Pharmaceuticals USA Inc., Pennington, New Jersey.
A Class II recall is 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.