FDA-Drug2017-06-07Class II
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
SCA Pharmaceuticals
Hazard
Lack of assurance of sterility: Product bags leaking at seam.
Sold states
Nationwide in the USA
Affected count
40 bags
Manufactured in
8821 Knoedl Ct, Little Rock, AR, United States
Products
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2017Don't want to check this manually?
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