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 (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 Recalled by QuVa Pharma, Inc. Due to Presence of Particulate matter: manufacturer recalled fentanyl API...

Date: November 12, 2019
Company: QuVa Pharma, 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 QuVa Pharma, Inc. directly.

Affected Products

fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37

Why Was This Recalled?

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About QuVa Pharma, Inc.

QuVa Pharma, Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

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