UTI Antibiotic Recalled

More than 70,000 single-dose sachets of fosfomycin tromethamine granules for oral solution distributed by Ascend Laboratories are recalled after samples of the product tested out-of-specification for organic impurities. The recall was included in the February 28, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects single-dose sachets of fosfomycin tromethamine granules for oral solution (NDC 67877-749-57), equivalent to 3 grams of fosfomycin, from the following lots: 

• 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, and 22121464 (Exp. 4/24);
• 22121176, 22121407, and 22121465 (Exp. 3/24); and
• 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, and 22121969 (Exp. 5/24).

The drug was manufactured by Alkem Laboratories in India. Ascend Laboratories, Parsippany, New Jersey, distributed the product throughout the United States. 

Ascend Laboratories voluntarily initiated the recall January 16, 2024. On February 20, 2024, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Fosfomycin tromethamine granules for oral solution is a prescription antibiotic indicated for the treatment of uncomplicated urinary tract infections in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.