LL-37 2 mg/mL Injection recalled over sterility concerns

Recall date

April 5, 2022

Source

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

Official notice title

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

Recall number

D-0778-2022

FDA classification

Class II

Brand / firm

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Sold / distributed

Nationwide within United States

Why it was recalled

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

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

What was recalled

LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA