Why it was recalled
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Product description
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Lot numbers, UPCs & expiration codes
Lot 23I21G64; Exp. 07/31/2024
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-0336-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 23, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 13,000 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0336-2024, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 93843
- Address
- 1 Baxter Pkwy
- Code information
- Lot 23I21G64; Exp. 07/31/2024
- Postal code
- 60015-4625
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0336-2024
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 13,000 bags
- Reason for recall
- Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2024