Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL) Recalled by Sagent Pharmaceuticals Inc Due to Lack of Assurance of Sterility; leaking of premix...

Date: March 4, 2014
Company: Sagent Pharmaceuticals Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sagent Pharmaceuticals Inc directly.

Affected Products

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

Quantity: 10,622 bags

Why Was This Recalled?

Lack of Assurance of Sterility; leaking of premix bags

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sagent Pharmaceuticals Inc

Sagent Pharmaceuticals Inc has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report