Status
Ongoing
Drug Enforcement D-0207-2025
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Classification
Class I
Report Date
January 29, 2025
Termination Date
—
Product Information
- Product description
- FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
- Product quantity
- 172 180-count bottles
- Reason for recall
- Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide via internet sales
Location & Firm
- Recalling firm
- SHOPPERS- PLAZA
- Address
-
Fouad Panchibyaya 12816
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0207-2025
- Event ID
- 95994
- Recall initiation date
- December 16, 2024
- Center classification date
- January 22, 2025
- Code info
- Batch # 001, exp. date 09/10/2026
- More code info
- —