Recalls / Class III
Class IIID-1063-2020
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.
- Affected lot / code info
- Lot # 5553.044E; 5553.044F, Exp. 04/30/2021
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, N/A, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- 900 Vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-02-24
- FDA classified
- 2020-03-25
- Posted by FDA
- 2020-03-04
- Terminated
- 2020-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1063-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.