Reported Aug 2, 2023 · Terminated

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL…

SCA Pharmaceuticals

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SCA Pharmaceuticals · 755 Rainbow Rd Ste B · Windsor, CT · 06095-1024

Is this the product you have?

  • 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
Lot codes and dates
  • Lot # 1223047134
  • Use By09/21/2023
Amount recalled
183 bags

Where it was sold

Why it was recalled

cGMP deviations: due to shipment of rejected units.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 21, 2023 · Data as of Sep 19, 6:38 PM UTC

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