Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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