Drug recall D-0784-2016

Class II Terminated reported Apr 6, 2016

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

Reason for recall

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

Lots and codes

Lot BS523, exp 10/2017

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
3,342 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 3, 2016
Terminated
May 3, 2017

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