Lupin recalls 35,928 bottles of Cefdinir, generic antibiotic drug in the US

Lupin is recalling 35,928 bottles of a generic antibiotic drug in the US market following unfavourable result in retention samples, informed the US FDA in a report.

As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), the company is recalling Cefdinir for oral suspension USP, 250 mg/5mL, packaged in 60 ml bottles.

The lot has been manufactured at Lupin’s Mandideep (Madhya Pradesh) manufacturing facility, and then supplied to company’s Baltimore-based arm, Lupin Pharmaceuticals Inc.

As per the USFDA, the company is recalling the specific lot due to out-of-specification (OOS) result observed in an assay test of retention samples.

Cefdinir is an antibiotic used to treat pneumonia, otitis media, strep throat, and cellulitis.

The ongoing voluntary recall has been classified as class II recall.

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.