Ketamine 50 mg/ in 0 recalled over sterility concerns

Recall date

August 16, 2019

Source

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

Official notice title

SCA Pharmaceuticals, LLC recalls Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Onl…

Recall number

D-1843-2019

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals, LLC

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Lack of Assurance of Sterility.

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 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.