# Quimica Sintetica, SA · 66-66 · SPAIN — FDA import alert red lists: firms subject to detention without physical examination

For Quimica Sintetica, SA · 66-66 · SPAIN, 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 SPAIN; product is Famitidine | Famotine HCl; product code is 60 S - S 22 Famotidine (Antacid), Active Pharm Ingred/Chems for Further Manuf | 62 V - S 05 Famotine HCl (Anti-Viral), Active Pharm Ingred/Chems for Further Manuf; date published is 09/30/2009; address is Calle Dulcinea S/N , Alcala De Henares, Madrid SPAIN, verified against its source on 2026-09-16.

- **Firm:** Quimica Sintetica, SA _(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:** SPAIN _(verified: appears in the quote below)_
- **Address:** Calle Dulcinea S/N , Alcala De Henares, Madrid SPAIN _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 60 S - S 22 Famotidine (Antacid), Active Pharm Ingred/Chems for Further Manuf | 62 V - S 05 Famotine HCl (Anti-Viral), Active Pharm Ingred/Chems for Further Manuf _(verified: each item appears in the quote below)_
- **Product:** Famitidine | Famotine HCl _(verified: each item appears in the quote below)_
- **FDA notes:** 11/2/2000 | 11/2/2000 _(verified: each item appears in the quote below)_

## What the source says

> Quimica Sintetica, SA Date Published : 09/30/2009 Calle Dulcinea S/N , Alcala De Henares, Madrid SPAIN 60 S - S 22 Famotidine (Antacid), Active Pharm Ingred/Chems for Further Manuf Date Published: 03/29/2019 Desc: Famitidine Notes: 11/2/2000 62 V - S 05 Famotine HCl (Anti-Viral), Active Pharm Ingred/Chems for Further Manuf Date Published: 03/29/2019 Desc: Famotine HCl 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/).