Roche Diagnostics GmbH · 66-66 · GERMANY

For Roche Diagnostics GmbH, import alert is 66-66; country is GERMANY; 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"; 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 2026-09-30.

What the source says

Roche Diagnostics GmbH Date Published : 09/30/2009 Sandhofer Str. 116 , Mannheim, Baden-Wurttemberg GERMANY

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

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_202.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.