Alkem, Caplin recall drugs in US market

Both the recalls were classified as a Class III recall by the US FDA

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Drugs manufactured by Indian pharma companies Alkem Laboratories and Caplin Steriles have been recently recalled from the US market, US Food and Drug Administration (US FDA) data showed.

Ascend Laboratories recalled 99,516 sachets of Fosfomycin Tromethamine Granules for Oral Solution in the US market. The reason for recall was stated as “out-of-specification results observed for the organic impurities test at 6 months, RT (room-temperature) stability” according to the daily US FDA Recall Information updates. The product was manufactured at Alkem Laboratories in India, which is Ascend’s parent company. The voluntary recall was initiated on 18 July. Fosfomycin Tromethamine Granules for Oral Solution is an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections) in women.

Caplin Steriles Limited recalled 19,820 vials of Milrinone Lactate Injection on August 14. The reason for recall was stated as “Failed Impurities/Degradation Specifications” according to the US FDA Enforcement report. The product was manufactured in Caplin’s Gummidipoondi plant. Milrinone is a medication indicated for cardiac support in patients with acute heart failure, pulmonary hypertension, or chronic heart failure. Caplin Steriles is a subsidiary of Caplin Point Laboratories Ltd.

Both the recalls were classified as a Class III recall by the US FDA. A Class III recall of products happens when “a situation in which use of, or exposure to, a volatile product is not likely to cause adverse health consequences”, the US FDA said.

Both the companies did not respond to emails for a response on the matter.

Shares of Caplin Point were trading at Rs. 1055, down 0.93 percent on NSE at 11.28 am on September 11. Shares of Alkem Laboratories were trading at Rs. 3638.95, up 0.49 percent on NSE at 11.29 am on September 11.