FDA Drug recall D-0104-2019
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class III recall of Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications: OOS for unknown impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0104-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-12 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11
Reason
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Identifiers
| ndc | 43598-331-11 |
|---|---|
| code_info | Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0104-2019%22
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