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Recall Observatory FDA recall evidence

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

March 03, 2016

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility