FDA-Drug2013-09-04Class II

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12

Hospira Inc.
Hazard

Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Sold states
Nationwide and Puerto Rico
Affected count
72,300 vials
Manufactured in
275 N Field Dr, Lake Forest, IL, United States
Products
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-927-2013

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