US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 3, 2016 (11 years ago)

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

What was recalled

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-688-52
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0784-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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