D-0076-2026 Class II Ongoing
FDA drug recall D-0076-2026 was initiated by GenoGenix LLC on July 30, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2025
- Initiation Date
- July 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
US Nationwide.
Code Information
All lots within expiry.