Lupin skids as failed USFDA specifications lead to recalls of 2 drugs

NEW DELHI: Shares of shed 1.6 per cent in early trade Monday after the drug manufacturing major said that it is recalling 50,832 bottles of Gatifloxacin Ophthalmic Solution, an antibiotic used to treat bacterial infections of the eyes.

As per the USFDA, the company's US-based unit is recalling the affected lot due to "failed stability specifications."

The company’s scrip fell to a low of Rs 937.15 as against Rs 951.80 at previous close on the National Stock Exchange.

The affected lot has been manufactured at Lupin's Pithampur-based plant in Madhya Pradesh, PTI reported, adding that the lot had been distributed in the US by Baltimore-based Lupin Pharmaceuticals Inc.

The drugmaker initiated Class III voluntary recall in the US and Puerto Rico on December 22 last year.

A Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences."

Lupin is also recalling 23,965 bottles of Oxycodone Hydrochloride tablets, used for the treatment of moderate to severe pain.

As per the USFDA, the company is recalling the lot due to the "out-of-specification impurity test result observed at 18-month long term stability time point."

The company's US-based subsidiary initiated Class III recall on December 29 last year.

In July-September, Lupin reported a net loss of Rs 2,095 crore.

During the quarter, the company booked a provision of Rs 1879.6 crore towards litigation and settlement related to diabetic drug Glumetza class actions as well as impairment expense of Rs 707.7 crore for specialty drug Solosec.