FDA-Drug2012-12-26Class II

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

Hospira, Inc.
Hazard

Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

Sold states
Nationwide and Puerto Rico.
Affected count
145,400 vials
Manufactured in
600 N Field Dr Bldg J45, Lake Forest, IL, United States
Products
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-096-2013

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