FDA: Hospira recalls emergency syringe drugs due to potential lack of sterility

Hospira, a Pfizer company, has voluntarily recalled certain lots of 8.4% sodium bicarbonate injection and other emergency syringe drugs distributed since January to hospitals and wholesalers in the United States, including Puerto Rico, because the drugs may not be sterile, the Food and Drug Administration announced last week. The recall includes 42 lots of 8.4% sodium bicarbonate injection; five lots of sodium bicarbonate 4% additive solution; five lots of succinylcholine chloride injection; and seven lots of potassium phosphates injection. A routine simulation of the manufacturing process detected microbial growth, meaning microorganisms may have been introduced into the products, according to the announcement. Anyone having the recalled products in their inventory should not use or distribute them, and may report any associated adverse reactions or quality problems to the FDA’s MedWatch program, the announcement states. FDA recently authorized the temporary import of a sodium bicarbonate injection product from Australia to address a critical shortage of the drug, commonly used in hospitals to treat a chemical imbalance in the blood. In April, Pfizer reported shortages of emergency drug syringes, including sodium bicarbonate. FDA last week extended the expiration dates for some of the Hospira drugs and is working with manufacturers to resolve the shortages. Meanwhile, the American Society of Health-System Pharmacists offers guidance and resources to help hospitals and health systems manage drug shortages, and the Association of State and Territorial Health Officials offers strategies to help mitigate the effects of emergency medication shortages.