Injectable Drug Recall: ARA-290 Due to Sterility Manufacturing Defects
ARA-290 (Cibinetide Acetate) injection is recalled due to manufacturing deviations that call sterility into question. Patients should contact their healthcare provider, as 28 vials have been distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with theoretical risk due to manufacturing deviations affecting sterility assurance. No illnesses, injuries, or confirmed contamination reported, limiting the score to High per the rubric.
Plain-English summary
ARA-290 (Cibinetide Acetate) 6 mg/mL injection in 4 mL vials, manufactured by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding, is being recalled. The recall includes Lot #32618 (beyond use date 4/4/2022) and Lot #34525 (beyond use date 5/24/2022), for a total of 28 vials distributed nationwide.
The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of this injectable product. For injectable medications intended to be sterile, such manufacturing deviations represent a potential health concern.
Patients who received this medication should contact their healthcare provider to discuss treatment options. Healthcare providers may consult with the FDA or manufacturer for additional guidance on patient management and monitoring.
The recalled product
- 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
- Manufacturer
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-defect
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 32618 BUD: 4/4/2022
- 34525 BUD: 5/24/2022
Distribution
Distributed nationwide across the United States.
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