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

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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