Pfizer Inc. recalls Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distribut…

Recall date

May 29, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1306-2020

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Distributed Nationwide in the US

Why it was recalled

Presence of Particulate Matter: particulate matter identified after reconstitution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83