FDA Recall D-0336-2024

Baxter Healthcare Corporation · Deerfield, IL

Class II Ongoing 842 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot 23I21G64; Exp. 07/31/2024

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 record

Recall number: D-0336-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-01-23
Classified by FDA Center: 2024-02-16
FDA published: 2024-02-28
Recalling firm: Baxter Healthcare Corporation
Firm location: Deerfield, IL

Drug identification

Brand name(s): NOREPINEPHRINE BITARTRATE
Generic name(s): NOREPINEPHRINE BITARTRATE
Manufacturer(s): Baxter Healthcare Corporation
NDC(s): 0338-0040, 0338-0112, 0338-0108, 0338-0116, 0338-0042, 0338-0128
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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