D-0103-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2018
- Initiation Date
- September 12, 2018
- Termination Date
- March 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,468 vials
Product Description
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.
Distribution Pattern
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
Code Information
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..