Class II · Moderate risk Ongoing
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Reason Lack of Assurance of Sterility: Leaking vials
Zoledronic Acid Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
What was recalled
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 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-0103-2019
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.
Other Zoledronic recalls
See all
Class III · Low risk Terminated
Zoledronic Acid Injection 5 mg/100 mL
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Class III · Low risk Terminated
Zoledronic Acid Injection
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class II · Moderate risk Terminated
Zoledronic Acid Injection
Reason Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Class II · Moderate risk Terminated
Zoledronic Acid active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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