FDA-Drug2017-11-08Class II

fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40

SCA Pharmaceuticals, LLC
Hazard

Lack Of Assurance Of Sterility.

Sold states
Nationwide in the United States
Affected count
116 bags
Manufactured in
8821 Knoedl Ct, N/A, Little Rock, AR, United States
Products
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0062-2018

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