PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 31, 2018 Initiated: September 20, 2018 #D-0095-2019

Product Description

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.

Details

Recalling Firm
Pfizer Inc.
Units Affected
71,075 vials
Distribution
Nationwide in the US and Puerto Rico
Location
New York, NY

Frequently Asked Questions

What product 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. Recalled by Pfizer Inc.. Units affected: 71,075 vials.
Why was this product recalled?
Lack of assurance of sterility: loss of container integrity.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0095-2019.