Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · 66-66 · JAPAN
For Second Tokushima Factory, 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 09/30/2009; address is 224-18 , Kawauchi-Cho , Tokushima, Tokushima JAPAN, verified against its source on 2026-09-16.
- Firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. verified
- 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
- Address
- 224-18 , Kawauchi-Cho , Tokushima, Tokushima JAPAN verified
- Date published
- 09/30/2009 verified
- 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. each item verified
- Product
- Agent for Schizophrenia | OPC-14597 - Agent | Mucosta each item verified
- FDA notes
- 11/2/2000 | 11/2/2000 | 11/2/2000 each item verified
What the source says
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. Date Published : 09/30/2009 224-18 , Kawauchi-Cho , Tokushima, Tokushima 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: 06/05/2019 Desc: Mucosta Notes: 11/2/2000
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_202.html