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.

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag Recalled by SCA Pharmaceuticals Due to cGMP deviations: due to shipment of rejected units.

Date: July 20, 2023
Company: SCA Pharmaceuticals
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 SCA Pharmaceuticals directly.

Affected Products

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40

Quantity: 183 bags

Why Was This Recalled?

cGMP deviations: due to shipment of rejected units.

Where Was This Sold?

This product was distributed to 2 states: KY, NJ

Affected (2 states)Not affected

About SCA Pharmaceuticals

SCA Pharmaceuticals has 107 total recalls tracked by RecallDetector.

Related Recalls

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