Drug recall D-1216-2015

Class I Terminated reported Jul 15, 2015

Product

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

Reason for recall

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Lots and codes

Lot #: 38-515-DK, Expiry: 1 FEB 2016.

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
150,950 Vials
Distribution
U.S. Nationwide including Guam.
Type
Voluntary: Firm initiated
Recall initiated
April 23, 2015
Terminated
January 26, 2016

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