Morphine sulfate 1 mg per mL in 0 recalled over sterility concerns

Recall date

October 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SCA Pharmaceuticals, LLC recalls morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphin…

Recall number

D-0064-2018

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals, LLC

Sold / distributed

Nationwide in the United States

Why it was recalled

Lack Of Assurance Of Sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205