Zoledronic Acid Injection 5 mg/100 mL recall: Impurity Out of Spec
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
Why was Zoledronic Acid Injection 5 mg/100 mL recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
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 # 5553.044E; 5553.044F, Exp. 04/30/2021
- Product
- Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Quantity
- 900 Vials
- Distribution
- Nationwide in the U.S.
- Recall date
- March 4, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)