# Akebono Corporation · 66-66 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For Akebono Corporation · 66-66 · JAPAN, import alert is 66-66; import alert name is "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"; country is JAPAN; product is Clemastine Fumarate; product code is 61 X - S 10 Clemastine (Anti-Histaminic), Active Pharm Ingred/Chems for Further Manuf; date published is 09/30/2009; address is 1 Chome 12-13 , Nihonbashimuro-Machi , Chuo, Tokyo JAPAN, verified against its source on 2026-09-16.

- **Firm:** Akebono Corporation _(verified: appears in the quote below)_
- **Import alert:** 66-66
- **Import alert name:** "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"
- **Country:** JAPAN _(verified: appears in the quote below)_
- **Address:** 1 Chome 12-13 , Nihonbashimuro-Machi , Chuo, Tokyo JAPAN _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 61 X - S 10 Clemastine (Anti-Histaminic), Active Pharm Ingred/Chems for Further Manuf _(verified: appears in the quote below)_
- **Product:** Clemastine Fumarate _(verified: appears in the quote below)_
- **FDA notes:** 11/2/2000 _(verified: appears in the quote below)_

## What the source says

> Akebono Corporation Date Published : 09/30/2009 1 Chome 12-13 , Nihonbashimuro-Machi , Chuo, Tokyo JAPAN 61 X - S 10 Clemastine (Anti-Histaminic), Active Pharm Ingred/Chems for Further Manuf Date Published: 10/09/2018 Desc: Clemastine Fumarate Notes: 11/2/2000

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_202.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).