Class II · Moderate risk
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Lack of Assurance of Sterility: Leaking vials
Zoledronic Acid Injection 5 mg per 100 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; leaking of premix bags
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
25021-0830-82
Compare with the code on your package — it is the most precise check available.
Drug: Zoledronic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| zoledronic acid NDC 25021-0830 |
.05 mg/mL | Injection, Solution Intravenous |
Sagent Pharmaceuticals | Rx |
- Recalling firm
- Sagent Pharmaceuticals Inc
- NDC code
- 25021-830-82
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1615-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Zoledronic recalls
See all
Class III · Low risk
Zoledronic Acid Injection 5 mg/100 mL
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Class III · Low risk
Zoledronic Acid Injection
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk
Zoledronic Acid Injection
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class II · Moderate risk
Zoledronic Acid Injection
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Other recalls by Sagent Pharmaceuticals Inc
All 2014 recalls
Class III · Low risk
Busulfan Injection
Failed Impurities/Degradation Specifications
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
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