Lupin, Heritage recall drugs in US

Pharmaceutical firm Lupin has initiated a nationwide voluntary recall of pneumonia antibiotic in the US after a complaint of metal piece in the bottle was received.

In a recent enforcement report, the US Food and Drug Administration (FDA) said Lupin Pharmaceuticals Inc, the US arm of Mumbai-based Lupin, has recalled 18,408 bottles of Cefdinir, 250mg/5ml powder for oral suspension in 60 ml bottle manufactured at Lupin’s Mandideep plant in Madhya Pradesh.

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

The reason for the recall is given as complaint received of metal piece identified in the product bottle prior to the reconstitution.

The ongoing Class II recall was initiated on May 23, the FDA said on its website. The products have an expiry date of November 2020.

A Class II recall is 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.

Another Class II recall specification was reported by Heritage Pharmaceutical Inc after it initiated a nationwide voluntary recall of 81,873 bottles of high blood pressure drug Losartan Potassium tablets in 25 mg, 50 mg, and 100 mg, with expiry between November 2019 and April 2020, after FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid in the finished product above the interim acceptable daily intake level at the manufacturer. 

The products were manufactured by Vivimed Life Sciences at its Kanchipuram plant. Losartan is also used for diabetic kidney disease, heart failure and left ventricular enlargement.

The pharma company also initiated a voluntary recall of Amikacin Sulfate Injection, 1g/4ml, with an expiry of October 2019, and Prochlorperazine Edisylate Injection, 10 mg/2ml, with an expiry of April 2020.

These drug products are manufactured by Emcure Pharmaceuticals and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected, which may indicate a lack of sterility in the other sub-lots.

Non-sterile injectable products that are intended to be sterile may result in a site-specific or systemic infection which may cause hospitalisation or death. Heritage has not received adverse event reports related to this event, the FDA notification said.