Drug recall D-1433-201

Class II Terminated reported Jul 23, 2014

Product

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

Reason for recall

Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.

Lots and codes

Lot #: 39474DK, Expiry: 03/01/2016.

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
47,400 vials
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 27, 2014
Terminated
September 9, 2015

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