FDA-Drug2017-06-07Class II

morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.

SCA Pharmaceuticals
Hazard

Lack of assurance of sterility: Product bags leaking at seam.

Sold states
Nationwide in the USA
Affected count
80 bags
Manufactured in
8821 Knoedl Ct, Little Rock, AR, United States
Products
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0870-2017

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