North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding: Drug Recall
Recall #D-0778-2022 · 04/05/2022
Class II: Risk
Recall Details
- Recall Number
- D-0778-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Status
- Terminated
- Date Initiated
- 04/05/2022
- Location
- Richardson, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 vials
Reason for Recall
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Product Description
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Distribution Pattern
Nationwide within United States
Other Recalls by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Class II: Risk 04/05/2022
- Class II: Risk 04/05/2022
- Class II: Risk 04/05/2022
- Class II: Risk 04/05/2022
- Class II: Risk 04/05/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.