Drug product
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
D-0784-2016
Product summary
- Event
- Event 73527
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,342 vials
- Official record key
drug-enforcement:D-0784-2016
Official wording
Reason: Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Code information: Lot BS523, exp 10/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility