SCA Pharmaceuticals product recalled over sterility concerns

Recall date

December 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SCA Pharmaceuticals recalls Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmac…

Recall number

D-0197-2021

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Product was distributed to hospitals nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012