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.

5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) Recalled by Pharmedium Services, LLC Due to Presence of Particulate Matter: API contaminated with glass...

Date: May 5, 2016
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

5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,

Quantity: 3,474 bags

Why Was This Recalled?

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pharmedium Services, LLC

Pharmedium Services, LLC has 246 total recalls tracked by RecallDetector.

Related Recalls

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