Drug recall D-1615-2014

Class II Terminated reported Oct 8, 2014

Product

Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82

Reason for recall

Lack of Assurance of Sterility; leaking of premix bags

Lots and codes

NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.

Recall details

Recalling firm
Sagent Pharmaceuticals Inc, Schaumburg, IL
Quantity
10,622 bags
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 4, 2014
Terminated
July 7, 2016

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