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Ascend Laboratories recalls over 20,000 bottles of antibacterial drug in US

Ascend Laboratories LLC, subsidiary of Mumbai-based Alkem Labs, is recalling over 20 thousand bottles of antibacterial drug Cephalexin for oral suspension from the US market, as per a report by the US drug regulator.

The US-based Ascend Laboratories LLC is recalling 20,232 bottles of Cephalexin for oral suspension, USP, 125 mg per 5 mL, manufactured by Alkem Laboratories, according to the latest Enforcement Report by the US Food and Drug Administration.

The reason for the ongoing nationwide voluntary recall is, “Failed Impurity/Degradation Specifications: unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL,” the report said.

The USFDA has classified the recall as a Class II recall, which according to the US drug regulator 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.

The company initiated the recall on November 23, 2020, the report said.

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