Recalls / Class II
Class IID-1615-2014
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
- Brand name
- Zoledronic Acid
- Generic name
- Zoledronic Acid
- Active ingredient
- Zoledronic Acid
- Route
- Intravenous
- NDC
- 25021-830
- FDA application
- ANDA202828
- Affected lot / code info
- NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Why it was recalled
Lack of Assurance of Sterility; leaking of premix bags
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Manufacturer
- Sagent Pharmaceuticals
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 700, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 10,622 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-03-04
- FDA classified
- 2014-09-29
- Posted by FDA
- 2014-10-08
- Terminated
- 2016-07-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1615-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.