NDC 55111-688
Zoledronic Acid 5 mg per 100 mL injection, solution
On the label: Dr.Reddy's Laboratories Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Hyderabad, India | Makes it and tests it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
| Gland Pharma Limited | Hyderabad, India | Makes it and tests it | Problems found, fixed voluntarilyJun 27, 2023 · 4 inspections |
Recalls
- May 23, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
Lack of Assurance of Sterility: Leaking vials
Lots: Lot #: G3000010, Exp. Date 11/2025 - Sep 12, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Lots: 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.. - Mar 3, 2016 · Class II · Dr. Reddy's Laboratories, Inc.
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Lots: Lot BS523, exp 10/2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Zoledronic Acid: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 5 mg per 100 mL
- Approval
- ANDA ANDA091363
- On the market since
- Apr 3, 2013
- Package NDCs
55111-688-52- Official label
- DailyMed (National Library of Medicine), updated Feb 10, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?