US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 5, 2022 (4 years ago)

LL-37 2 mg/mL

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

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

Recalling firm
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0778-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.