Why it was recalled
Labeling: Label mix-up
Product description
NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
Lot numbers, UPCs & expiration codes
Lot: 12112018@24 Exp. 01/25/2019
Where it was sold
Nationwide in the USA
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-1078-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 16, 2019
- FDA report date
- Apr 10, 2019
- Quantity
- 190 250 mL bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KRS Global Biotechnology, Inc
Original FDA data
Every field from FDA enforcement report D-1078-2019, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 82509
- Address
- 791 Park of Commerce Blvd Ste 600
- Code information
- Lot: 12112018@24 Exp. 01/25/2019
- Postal code
- 33487-3633
- Report date
- Apr 10, 2019
- Product type
- Drugs
- Recall number
- D-1078-2019
- Classification
- Class II
- Recalling firm
- KRS Global Biotechnology, Inc
- Product quantity
- 190 250 mL bags
- Termination date
- Feb 4, 2021
- Reason for recall
- Labeling: Label mix-up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 16, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2019