# Otsuka Pharmaceutical Co Ltd · 66-66 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For Otsuka Pharmaceutical Co Ltd · 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 Agent for Schizophrenia | OPC-14597 - Agent | Mucosta; product code is 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/02/2019; address is 2-27 3-Chome Otedori cho U , Koku-Machi; Chuo , Osaka, Osaka JAPAN, verified against its source on 2026-09-16.

- **Firm:** Otsuka Pharmaceutical Co Ltd _(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:** 2-27 3-Chome Otedori cho U , Koku-Machi; Chuo , Osaka, Osaka JAPAN _(verified: appears in the quote below)_
- **Date published:** 04/02/2019 _(verified: appears in the quote below)_
- **Product code:** 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Agent for Schizophrenia | OPC-14597 - Agent | Mucosta _(verified: each item appears in the quote below)_
- **FDA notes:** 11/2/2000 | 11/2/2000 | 11/2/2000 _(verified: each item appears in the quote below)_

## What the source says

> Otsuka Pharmaceutical Co Ltd Date Published : 04/02/2019 2-27 3-Chome Otedori cho U , Koku-Machi; Chuo , Osaka, Osaka JAPAN 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf Date Published: 04/02/2019 Desc: Agent for Schizophrenia Notes: 11/2/2000 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf Date Published: 04/02/2019 Desc: OPC-14597 - Agent Notes: 11/2/2000 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/02/2019 Desc: Mucosta 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/).