Drug recall D-0103-2019

Class III Terminated reported Oct 3, 2018

Product

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52

Reason for recall

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Lots and codes

Batch Numbers: BS633, EXP 9/2018; BS701, BS702, BS703, EXP 12/2018; BS708, BS709, BS711, BS712, BS713, BS714, BS715, EXP 3/2019; BS726, BS727, EXP 6/2019; BS728, BS729, BS730, EXP 7/2019; BS801, EXP 03/2020..

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
59,468 vials
Distribution
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Type
Voluntary: Firm initiated
Recall initiated
September 12, 2018
Terminated
March 3, 2020

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