Antibiotic Injection Recalled

Pfizer Inc. is recalling a single lot of Unasyn (ampicillin sodium/sulbactam) for injection after a customer reported particulate matter in a vial. The recall was included in the June 17, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects Unasyn for injection, 1.5 g per vial, 10 vials/carton (vial NDC 0049-0013-81, carton NDC 0049-0013-83) from lot 3301612 (Exp. 2/22). The vials were distributed throughout the United States.  

Pfizer initiated the voluntary recall May 29, 2020.

“The use of the impacted product has an unlikely probability of being associated with adverse events such as infection or embolic events,” the company wrote in a May 29, 2020, letter notifying customers of the recall. “To date, Pfizer has not received reports of any adverse events for this lot and the potential risk to the patient arising from this issue is low.” 

On June 12, 2020, the FDA designated the recall Class II, communicating use of the product may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Unasyn is a prescription antibiotic used to treat bacterial infections.

—Jolynn Tumolo