Leading drug makers Dr Reddy’s Laboratories and Zydus Pharma are recalling bottles of a product each, in the US market, for different reasons, according to the latest report of the US health regulator.
Dr Reddy’s Laboratories, Inc, the US arm of Dr Reddy’s Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg, the latest enforcement report by the US Food and Drug Administration (USFDA) said.
The tablets are manufactured by Dr Reddy’s Laboratories Ltd at its Srikakulam facility, it added.
The product is used to treat the symptoms of muscle stiffness associated with conditions such as cerebral palsy or other neurological disorders.
The reason for the recall is, “Failed Tablet/Capsule Specification: Some tablets are shaved”, the report said.
The voluntary ongoing nationwide within the United States recall is a class II recall, it added.
As per the report by the USFDA, Zydus Pharmaceuticals (USA) Inc, is recalling 2,880 bottles of Carvedilol tablets, USP 25 mg in the US due to, “presence of foreign tablets/ capsules; report of two Paroxetine tablets were found in the bottle.”
Carvedilol tablets are used to treat high blood pressure and heart failure.
The voluntary ongoing nationwide in the US recall is a class II recall, the report by the US health regulator said.
The tablets have been manufactured by Cadila Healthcare Ltd, and are distributed by Zydus Pharmaceuticals (USA) Inc, it added.
Zydus Pharmaceuticals (USA) Inc is the US arm of Zydus Cadila Healthcare.
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.
Source: Business Standard