Drug recall D-1425-2014

Class II Terminated reported Jul 16, 2014

Product

Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62

Reason for recall

Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.

Lots and codes

Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
142,152 bags
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 6, 2014
Terminated
April 3, 2015

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