Meropenem for Injection recalled over sterility concerns

Recall date

September 20, 2018

Source

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

Official notice title

Pfizer Inc. recalls Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc…

Recall number

D-0095-2019

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide in the US and Puerto Rico

Why it was recalled

Lack of assurance of sterility: loss of container integrity.

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

What was recalled

Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11