Bronchodilator Recalled

Pfizer Inc is recalling 103,150 vials of aminophylline injection after receiving a report of a hair found in a vial, according to the October 12, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects aminophylline injection, 250 mg/10 mL (25 mg/mL), 10-mL single-dose vials (NDC 0409-5921-16) packaged in cartons containing 25 vials (NDC 0409-5921-01), from lot 30-137-DK (Exp. 12/1/22). The recalled injections were distributed by Hospira Inc, Lake Forest, IL, throughout the United States and in Puerto Rico.

Pfizer voluntarily initiated the recall September 27, 2022. The FDA designated it Class II on October 4, 2022. The classification communicates use of the product may cause temporary or medically reversible adverse health consequences, with a remote possibility of serious harm.

Aminophylline injection is a prescription bronchodilator used in the treatment of acute exacerbations of symptoms associated with asthma and other chronic lung diseases.