# Roche Diagnostics GmbH · 66-66 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Roche Diagnostics GmbH · 66-66 · GERMANY, 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 GERMANY; product is Amitriptyline HCl | Metaxalone; product code is 61 N - S 03 Amitriptyline HCl (Anti-Depressant), Active Pharm Ingred/Chems for Further Manuf | 65 Q - S 21 Metaxalone (Relaxant), Active Pharm Ingred/Chems for Further Manuf; date published is 09/30/2009; address is Sandhofer Str. 116 , Mannheim, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-16.

- **Firm:** Roche Diagnostics GmbH _(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:** GERMANY _(verified: appears in the quote below)_
- **Address:** Sandhofer Str. 116 , Mannheim, Baden-Wurttemberg GERMANY _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 61 N - S 03 Amitriptyline HCl (Anti-Depressant), Active Pharm Ingred/Chems for Further Manuf | 65 Q - S 21 Metaxalone (Relaxant), Active Pharm Ingred/Chems for Further Manuf _(verified: each item appears in the quote below)_
- **Product:** Amitriptyline HCl | Metaxalone _(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

> Roche Diagnostics GmbH Date Published : 09/30/2009 Sandhofer Str. 116 , Mannheim, Baden-Wurttemberg GERMANY 61 N - S 03 Amitriptyline HCl (Anti-Depressant), Active Pharm Ingred/Chems for Further Manuf Date Published: 02/01/2022 Desc: Amitriptyline HCl Notes: 11/2/2000 65 Q - S 21 Metaxalone (Relaxant), Active Pharm Ingred/Chems for Further Manuf Date Published: 02/01/2022 Desc: Metaxalone 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/).