PFIZER recalls Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Fore…

Recall date

June 28, 2018

Source

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

Recall number

D-1023-2018

FDA classification

Class II

Brand / firm

PFIZER

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.

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

What was recalled

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.