D-0103-2019 Class III Terminated
FDA drug recall D-0103-2019 was initiated by Dr. Reddy's Laboratories, Inc. on Sep 12, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: OOS for unknown impurities. The recall status is terminated (terminated Mar 3, 2020). Affected quantity: 59,468 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 3, 2018
- Initiation Date
- Sep 12, 2018
- Termination Date
- Mar 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..
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0103-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026