FDA-Drug2014-12-24Class II

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

Hospira Inc.
Hazard

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.

Sold states
Nationwide and Puerto Rico, Italy, Netherland, Spain
Affected count
261,706 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0303-2015

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