PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 8, 2017 Initiated: October 19, 2017 #D-0066-2018

Product Description

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

Reason for Recall

Lack Of Assurance Of Sterility.

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
1221 syringes
Distribution
Nationwide in the United States
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
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. Recalled by SCA Pharmaceuticals, LLC. Units affected: 1221 syringes.
Why was this product recalled?
Lack Of Assurance Of Sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0066-2018.