FDA recall D-0095-2019

Product

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

Reason for recall

Lack of assurance of sterility: loss of container integrity.

Distribution

Nationwide in the US and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-09-20

Report date

2018-10-31

Termination date

2022-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2019