Zoledronic Acid Injection recall: Sterility Concern
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC…
Why was Zoledronic Acid Injection recalled?
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
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?
Lot BS523, exp 10/2017
- Product
- Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC…
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 3,342 vials
- Distribution
- Nationwide
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)