FDAFDA · Food and drugs·Recall number D-1615-2014
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
Published October 8, 2014 · Recall initiated: March 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; leaking of premix bags
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- ZOLEDRONIC ACID
- Manufacturer
- Sagent Pharmaceuticals Inc
- Distributor
- Nationwide
- Lot
- NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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