Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 5553.044E; 5553.044F, Exp. 04/30/2021
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1063-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 24, 2020
- FDA report date
- Mar 4, 2020
- Quantity
- 900 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-1063-2020, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 85054
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot # 5553.044E; 5553.044F, Exp. 04/30/2021
- Postal code
- 06037-2352
- Report date
- Mar 4, 2020
- Product type
- Drugs
- Recall number
- D-1063-2020
- Classification
- Class III
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 900 Vials
- Termination date
- Aug 31, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Feb 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2020