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FDANovember 9, 2023drug

fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132

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

The hazard

Lack of Assurance of Sterility

What to do

FDA enforcement status: Terminated

Brands named

sca pharmaceuticalssca

UPCs

70004023132

Recall history

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

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fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132 — Recall Details · AllClear