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 (as citrate) in 0.9% Sodium Chloride injectable Recalled by SCA Pharmaceuticals Due to Lack of assurance of sterility: Product bags leaking...

Date: May 18, 2017
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 (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32

Quantity: 370 bags

Why Was This Recalled?

Lack of assurance of sterility: Product bags leaking at seam.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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