PlainRecalls
FDA Drug Moderate Class II Terminated

Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01

Reported: December 24, 2014 Initiated: October 24, 2014 #D-0303-2015

Product Description

Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01

Reason for Recall

Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.

Details

Recalling Firm
Hospira Inc.
Units Affected
261,706 vials
Distribution
Nationwide and Puerto Rico, Italy, Netherland, Spain
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01. Recalled by Hospira Inc.. Units affected: 261,706 vials.
Why was this product recalled?
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 24, 2014. Severity: Moderate. Recall number: D-0303-2015.