Zoledronic Acid Injection recall: Impurity Out of Spec
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…
Why was Zoledronic Acid Injection recalled?
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019.
- 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…
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 10,530 vials
- Distribution
- Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
- Recall date
- October 3, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)