FDAFDA · Food and drugs·Recall number D-0778-2022
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Published April 27, 2022 · Recall initiated: April 5, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Distributor
- Nationwide within United States
- Lot
- Lot #: 33444 BUD: 4/26/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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