Food product
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
H-0569-2026
Product summary
- Event
- Event 97884
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 422cs/12/0.25mg/100ct bottles + 210cs/12/1.0mg/100ct bottles
- Official record key
food-enforcement:H-0569-2026
Official wording
Reason: Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
Code information: Lot 1692303 SN: 138909557498 EXP: 2025-10-26 & Lot 1692304 SN 131163901709 EXP: 2025-10-26; LOT 1712301 SN: 163590222021 EXP: 2025-11-14
Distribution pattern: Product was shipped to the following states: AL, AZ, CA, FL, HI, IA, IL, IN, MA, MI, MO, MS, NC, NJ, NY, OR, PA, PR, RI, TN, TX, UT, WA, WI & WV.
Derived failure modes
-
Potency or specification failure
Subpotent