D-0138-2024 Class I Ongoing
FDA drug recall D-0138-2024 was initiated by SUGARMDS LLC on November 8, 2023 and is designated Class I. Reason for recall: MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide The recall status is ongoing. Affected quantity: 32,117.
Recall Details
- Product Type
- Drugs
- Report Date
- December 13, 2023
- Initiation Date
- November 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,117
Product Description
Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.
Reason for Recall
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Distribution Pattern
U.S. Nationwide and online websites.
Code Information
LOT# 22165-003, EXP 09/30/2024