Roche Diagnostics GmbH · 66-66 · GERMANY
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
- 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
- Address
- Sandhofer Str. 116 , Mannheim, Baden-Wurttemberg GERMANY verified
- Date published
- 09/30/2009 verified
- 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 each item verified
- Product
- Amitriptyline HCl | Metaxalone each item verified
- FDA notes
- 11/2/2000 | 11/2/2000 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_202.html
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