Why it was recalled
Lack of Assurance of Sterility
Product description
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide
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-0042-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 12, 2019
- FDA report date
- Oct 9, 2019
- Quantity
- 6568 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KRS Global Biotechnology, Inc
Original FDA data
Every field from FDA enforcement report D-0042-2020, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83789
- Address
- 791 Park of Commerce Blvd Ste 600
- Code information
- All lots remaining within expiry.
- Postal code
- 33487-3633
- Report date
- Oct 9, 2019
- Product type
- Drugs
- Recall number
- D-0042-2020
- Classification
- Class II
- Recalling firm
- KRS Global Biotechnology, Inc
- Product quantity
- 6568 vials
- Termination date
- Aug 19, 2021
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 12, 2019
- Initial firm notification
- Press Release
- Center classification date
- Oct 1, 2019