Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 Recalled by KRS Global Biotechnology, Inc Due to Lack of Assurance of Sterility

Date: September 12, 2019
Company: KRS Global Biotechnology, Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact KRS Global Biotechnology, Inc directly.

Affected Products

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401

Quantity: 60 bags

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About KRS Global Biotechnology, Inc

KRS Global Biotechnology, Inc has 129 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report