FDA-Drug2018-10-31Class II

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

Pfizer Inc.
Hazard

Lack of assurance of sterility: loss of container integrity.

Sold states
Nationwide in the US and Puerto Rico
Affected count
71,075 vials
Manufactured in
235 E 42nd St, N/A, New York, NY, United States
Products
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

Official notice

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

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