FDA-Drug2017-11-08Class II

fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64

SCA Pharmaceuticals, LLC
Hazard

Lack Of Assurance Of Sterility.

Sold states
Nationwide in the United States
Affected count
20 bags inside rigid translucent plastic cases (CADD)
Manufactured in
8821 Knoedl Ct, N/A, Little Rock, AR, United States
Products
fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0063-2018

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