FDA-Drug2017-11-08Class II

PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12

SCA Pharmaceuticals, LLC
Hazard

Lack Of Assurance Of Sterility.

Sold states
Nationwide in the United States
Affected count
1221 syringes
Manufactured in
8821 Knoedl Ct, N/A, Little Rock, AR, United States
Products
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0066-2018

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