Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Inf...
FDA Drug Recall #D-0336-2024 — Class II — January 23, 2024
Recall Summary
| Recall Number | D-0336-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 23, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Deerfield, IL |
| Product Type | Drugs |
| Quantity | 13,000 bags |
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
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.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot 23I21G64; Exp. 07/31/2024
Other Recalls from Baxter Healthcare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0296-2026 | Class II | Sterile Water for Irrigation, 250 mL, Single-Do... | Dec 22, 2025 |
| D-0596-2025 | Class II | Acetaminophen Injection 1000 mg/100 mL (10 mg/m... | Aug 20, 2025 |
| D-0039-2025 | Class II | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL)... | Oct 30, 2024 |
| D-0649-2024 | Class I | Heparin (Heparin Sodium in 0.9% Sodium Chloride... | Aug 1, 2024 |
| D-0587-2024 | Class II | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dial... | Jun 17, 2024 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.