Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Ongoing
Report date
2024-02-28
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
13,000 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason 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.
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
Code / lot info
Lot 23I21G64; Exp. 07/31/2024
Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.