NEW DELHI, Jan 9: Drug major Lupin is recalling over 23,000 bottles of an antibiotic drug in the US for being sub-potent, US Food and Drug Administration (USFDA) said.
As per the latest Enforcement Report issued by the USFDA, Lupin Somerset is recalling 23,460 bottles of Nitrofurantoin oral suspension which is used to treat or prevent certain bladder infections.
The company is recalling the lot “due to below specification results for assay”, it added.
The drug is manufactured by Novel Laboratories Inc for Baltimore-based Lupin Pharmaceuticals, Inc.
The ongoing, voluntary recall is a class II recall, the report said.
As per 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.
(PTI)
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