Reference Source

Otsuka Pharmaceutical Co Ltd · 66-66 · JAPAN

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
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
2-27 3-Chome Otedori cho U , Koku-Machi; Chuo , Osaka, Osaka JAPAN verified
Date published
04/02/2019 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

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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