Lupin Recalls 35,928 Bottles Of Generic Antibiotic Drug In U.S.
The lot has been manufactured at Lupin's Mandideep, Madhya Pradesh manufacturing facility.
Lupin Ltd. is recalling 35,928 bottles of a generic antibiotic drug in the U.S. market following unfavourable result in retention samples.
According to the latest Enforcement Report of the U.S. Food and Drug Administration, the Mumbai-based company is recalling Cefdinir for oral suspension USP, 250 mg/5mL, packaged in 60 ml bottles. Cefdinir is an antibiotic used to treat pneumonia, otitis media, strep throat, and cellulitis.
The lot has been manufactured at Lupin's Mandideep, Madhya Pradesh manufacturing facility, and then supplied to the drugmaker's Baltimore-based arm, Lupin Pharmaceuticals, Inc., which has initiated the country-wide recall on July 2.
According to the U.S. FDA, the company is recalling the specific lot due to "out-of-specification result observed in an assay test of retention samples."
The ongoing voluntary recall has been classified as class-II. According to the U.S. 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.
The company did not elaborate if the product is also sold in India. A mail sent to the company in this regard remained unanswered.
Usually, drugmakers cater to the domestic market from separate manufacturing plants. The U.S. FDA approved facilities are specifically utilised to cater to the U.S., the largest market for pharmaceutical products in the world.
According to an earlier report of the regulator, the Mumbai-based firm is also in the process of recalling 4,92,858 bottles of Metformin Hydrochloride extended-release tablets in 500 mg and 1,000 strengths due to possibility of the affected lot containing cancer causing nitrosodimethylamine (NDMA) above the acceptable intake limit.