D-0626-2024 Class I Ongoing
FDA drug recall D-0626-2024 was initiated by MAIN PRODUCTS INC on July 18, 2024 and is designated Class I. Reason for recall: Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole. The recall status is ongoing. Affected quantity: 57, 340 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2024
- Initiation Date
- July 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57, 340 bottles
Product Description
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Reason for Recall
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Distribution Pattern
Nationwide within the U.S
Code Information
All lots within expiry