FDA-Device2025-11-05Class IIMISBRANDING

Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;

FALSE CLAIMSNationwide distributionMedical devices
Hazard

Product lacks 510(k) clearance.

Intended for
Adults (12 years to 50 years)
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
3074 packs
Manufactured in
Biscuit Factory Business Complex, 100 Drummond Road, London, N/A, United Kingdom
Products
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2026

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