FDA-Drug2016-04-06Class II
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
Dr. Reddy's Laboratories, Inc.
Hazard
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Sold states
Nationwide
Affected count
3,342 vials
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0784-2016Don't want to check this manually?
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