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FDAJuly 20, 2023drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

cGMP deviations: due to shipment of rejected units.

What to do

FDA enforcement status: Terminated

Brands named

sca pharmaceuticalssca

UPCs

70004025340

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear