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.

100 mcg / mL Phenylephrine HCl (Preservative Free) Injection Recalled by PharMEDium Services, LLC Due to Lack of assurance of sterility: Three lots were...

Date: February 5, 2018
Company: PharMEDium Services, LLC
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 PharMEDium Services, LLC directly.

Affected Products

100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC

Quantity: 500 syringes

Why Was This Recalled?

Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

Where Was This Sold?

This product was distributed to 4 states: FL, NY, SC, WA

Affected (4 states)Not affected

About PharMEDium Services, LLC

PharMEDium Services, LLC has 21 total recalls tracked by RecallDetector.

Related Recalls

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