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FDARecalled Apr 3, 2024 · #D-0398-2024

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 Yellow CADD Cassette, Rx only, SCA Pharmaceu...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility Classification: Class II Distribution: Nationwide in the USA

Product details

Product
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 Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
Type
Drugs
Manufacturer
SCA Pharmaceuticals, LLC
Model numbers
1223049754
UPCs