FDA-Drug2017-06-07Class II

PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32

SCA Pharmaceuticals
Hazard

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

Sold states
Nationwide in the USA
Affected count
30 bags
Manufactured in
8821 Knoedl Ct, Little Rock, AR, United States
Products
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0879-2017

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