Hormone Solutions Recalled

More than 160,000 bags of oxytocin solution are being recalled by Central Admixture Pharmacy Services Inc because of a lack of assurance of sterility. The recall was prompted by a US Food and Drug Administration inspection that brought the sterility of the products into question, according to the May 31, 2023, FDA Enforcement Report.

The recall affects the following products, which were distributed throughout the United States by Central Admixture Pharmacy Services, Allentown, Pennsylvania:

• oxytocin 20 units added to dextrose 5%/lactated Ringer’s 1000 mL per bag (NDC 71285-6031-1);
• oxytocin 30 units added to dextrose 5%/lactated Ringers 500 mL per bag (NDC 71285-6032-1);
• oxytocin 10 units added to lactated Ringer's 500 mL per bag (NDC 72185-6036-1);
• oxytocin 15 units added to lactated Ringer’s 250 mL per bag (NDC 71285-6037-1);
• oxytocin 20 units added to lactated Ringer’s 1000 mL per bag (NDC 71285-6038-1);
• oxytocin 30 units added to lactated Ringer’s 500 mL per bag (NDC 71285-6039-1);
• oxytocin 15 units added to .9% sodium chloride, 250 mL per bag (NDC 72185-6042-1);
• oxytocin 20 units added to .9% sodium chloride 1000 mL per bag (NDC 72185-6043-1);
• oxytocin 30 units added to .9% sodium chloride 500 mL per bag (NDC 71285-6044-1);
• oxytocin 60 units added to .9% sodium chloride 1,000 mL per bag (NDC 71285-6045-1); and
• oxytocin 40 units added to .9% sodium chloride 1000 bag (NDC 71285-8069-1).

The FDA Enforcement Report includes details for each recalled solution, including lot numbers and expiration dates.

The recalls were initiated voluntarily by Central Admixture Pharmacy Services on April 28, 2023. On May 19, 2023, the FDA designated them Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Oxytocin is an oxytocic hormone used to improve contractions during labor, to reduce bleeding after childbirth, or, with other medications or procedures, to end a pregnancy.