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Companies / North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0776-2022 | Class II | BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, T | April 5, 2022 |
| D-0775-2022 | Class II | ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenvi | April 5, 2022 |
| D-0777-2022 | Class II | Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmak | April 5, 2022 |
| D-0781-2022 | Class II | Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave R | April 5, 2022 |
| D-0780-2022 | Class II | PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Green | April 5, 2022 |
| D-0779-2022 | Class II | Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richard | April 5, 2022 |
| D-0778-2022 | Class II | LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX | April 5, 2022 |