CLASS II Drug recall · Reported 8 Oct 2014 · FDA Enforcement Report
Zoledronic Acid Injection 5 mg per 05 mg/mL) single-use recalled
Sagent Pharmaceuticals is recalling Zoledronic Acid Injection 5 mg per 05 mg/mL) single-use, distributed nationwide in the US. The recall was initiated on 4 Mar 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1615-2014
- FDA event ID
- 67689
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Brand
- Zoledronic Acid
- Manufacturer
- Sagent Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2014
- FDA classified
- 29 Sep 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Mar 2014 | Recall initiated by company | |
| 29 Sep 2014 | Classified by FDA | +209 days |
| 8 Oct 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; leaking of premix bags
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Zoledronic Acid Injection 5 mg per 05 mg/mL) single-use recalled?
Yes. Sagent Pharmaceuticals recalled Zoledronic Acid Injection 5 mg per 05 mg/mL) single-use on 4 Mar 2014. The recall is Class II and its status is Terminated. Recall number D-1615-2014.
Why was it recalled?
Lack of Assurance of Sterility; leaking of premix bags
Which lots are affected?
NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sagent Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per pharmacy, For Intravenous Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
Other Zoledronic Acid recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalledZoledronic Acid | Dr. Reddy's Laboratories | Sterility | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection 5 mg/ 05 mg/mL), Solution recalled | Breckenridge Pharmaceutical | Sterility | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5mg/ 05 mg/mL) vial recalledZoledronic Acid | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5 mg/ 05 mg/mL) One Single-Dose recalledZoledronic Acid | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Zoledronic Acid Injection, 5 mg/ 05 mg/mL) Single Use recalledZoledronic Acid | Dr. Reddy's Laboratories | Foreign Material | Nationwide |