Drug product
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
D-0298-2025
Product summary
- Event
- Event 96334
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 57,184 bottles
- Official record key
drug-enforcement:D-0298-2025
Official wording
Reason: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Code information: Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed stability specifications