Recalls / Class II
Class IID-0775-2022
Product
ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
- Affected lot / code info
- Lot #: 32618 BUD: 4/4/2022; 34525 BUD: 5/24/2022
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.
Recalling firm
- Firm
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1736 N Greenville Ave, Richardson, Texas 75081-1808
Distribution
- Quantity
- 28 vials
- Distribution pattern
- Nationwide within United States
Timeline
- Recall initiated
- 2022-04-05
- FDA classified
- 2022-04-21
- Posted by FDA
- 2022-04-27
- Terminated
- 2023-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0775-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.