Status
Ongoing
Drug Enforcement D-0336-2024
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.
Classification
Class II
Report Date
February 28, 2024
Termination Date
—
Product Information
- 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
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Baxter Healthcare Corporation
- Address
-
1 Baxter Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0336-2024
- Event ID
- 93843
- Recall initiation date
- January 23, 2024
- Center classification date
- February 16, 2024
- Code info
- Lot 23I21G64; Exp. 07/31/2024
- More code info
- —