RecallDepth
Class II Terminated

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

Company
Sagent Pharmaceuticals Inc
Recall Initiated
March 4, 2014
Posted
October 8, 2014
Recall Number
D-1615-2014
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
10,622 bags
Firm Location
Schaumburg, IL, United States

Reason for Recall

Lack of Assurance of Sterility; leaking of premix bags

Distribution

Nationwide

Lot / Code Info

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

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