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FDAMarch 3, 2016drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

dr reddy s laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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