PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 13, 2021 Initiated: December 17, 2020 #D-0213-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
SCA Pharmaceuticals
Units Affected
9416 syringes
Distribution
Product was distributed to hospitals nationwide.
Location
Windsor, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by SCA Pharmaceuticals. Units affected: 9416 syringes.
Why was this product recalled?
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Which agency issued this recall?
This recall was issued by the FDA Drug on January 13, 2021. Severity: Moderate. Recall number: D-0213-2021.