Recalls / Class II
Class IID-0336-2024
Product
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
- Brand name
- Norepinephrine Bitartrate
- Generic name
- Norepinephrine Bitartrate
- Active ingredient
- Norepinephrine Bitartrate
- Route
- Intravenous
- NDCs
- 0338-0040, 0338-0112, 0338-0108, 0338-0116, 0338-0042, 0338-0128
- FDA application
- NDA214313
- Affected lot / code info
- Lot 23I21G64; Exp. 07/31/2024
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.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 13,000 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-23
- FDA classified
- 2024-02-16
- Posted by FDA
- 2024-02-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0336-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.