Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Reported: May 29, 2024 Initiated: April 29, 2024 #D-0508-2024
Product Description
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Reason for Recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Details
- Recalling Firm
- Hikma Injectables USA Inc
- Distribution
- CO, GA, PA, SD, WA
- Location
- Dayton, NJ
Frequently Asked Questions
What product was recalled? ▼
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25. Recalled by Hikma Injectables USA Inc.
Why was this product recalled? ▼
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2024. Severity: Critical. Recall number: D-0508-2024.
Related Recalls
FDA Drug Moderate
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…
Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…
Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…
Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical
Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC · 2026-02-11