NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only,...

FDA Drug Recall #D-1079-2019 — Class II — January 16, 2019

Recall Summary

Recall Number D-1079-2019
Classification Class II — Moderate risk
Date Initiated January 16, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm KRS Global Biotechnology, Inc
Location Boca Raton, FL
Product Type Drugs
Quantity 433 250 mL bags

Product Description

NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481

Reason for Recall

Labeling: Label mix-up

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot: 12122018@7 Exp. 02/10/2019

Other Recalls from KRS Global Biotechnology, Inc

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D-0114-2020 Class II Vitamin 9A/B Lyophilized, Vial For IM Use, Rx O... Sep 12, 2019
D-0054-2020 Class II GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in ... Sep 12, 2019
D-0100-2020 Class II Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC ... Sep 12, 2019
D-0078-2020 Class II NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg... Sep 12, 2019
D-0092-2020 Class II Quadmix # 19 (Prostaglandin E1-0.75 mg / Papave... Sep 12, 2019

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.