FDA recall D-1306-2020

Product

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

Reason for recall

Presence of Particulate Matter: particulate matter identified after reconstitution.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-05-29

Report date

2020-06-17

Termination date

2022-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1306-2020