The reason for the recall is “failed impurities/degradation specifications: out of specification for an unknown impurity was observed during the 18-month stability testing,” the report said
Unichem Laboratories is recalling 96,876 bottles of Bisoprolol Fumarate tablets used for the treatment of hypertension from the US market.
Unichem Pharmaceuticals USA Inc is recalling the tablets in the strength of 5 mg manufactured by Unichem Laboratories at its Goa plant, US FDA said in its latest Enforcement Report.
The reason for the recall is “failed impurities/degradation specifications: out of specification for an unknown impurity was observed during the 18-month stability testing,” the report said.
The voluntary ongoing nationwide recall is a class II recall, it said.
As per US FDA, 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”.
Unichem Pharmaceuticals USA, Inc is a wholly-owned subsidiary of Unichem Laboratories.
Comments are closed.