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FDAFDA · Food and drugs·Recall number D-0303-2015

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

Published December 24, 2014 · Recall initiated: October 24, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Hospira Inc.
Distributor
Nationwide and Puerto Rico, Italy, Netherland, Spain
Lot
Lot #: 609E014, Exp 1/2016; 609E015, Exp 1J/2016; 609E016, Exp 1/2016; 609E017, Exp 1/2016; 609E018, Exp 1/2016; 609E019, Exp 1/2016; 601E025, Exp 1/2016; 601E027, Exp 1/2016; 601E028A, Exp 1/2016; 601E028B, Exp 1/2016; 601E028C, Exp 1/2016
Risk classification
Class II
Area (FDA)
drug
Country
United States

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