FDA-Drug2021-01-13Class II

ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409

SCA Pharmaceuticals
Hazard

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Sold states
Product was distributed to hospitals nationwide.
Affected count
9416 syringes
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2021

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