Galenus Mannheim · 66-66 · GERMANY
For Galenus Mannheim, 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 Methyldopa | Digoxin | Metaxalone; product code is 62 C - S 39 Methyldopate HCl (Anti-Hypertensive), Active Pharm Ingred/Chems for Further Manuf | 63 F - S 06 Digoxin (Cardiotonic), 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.
- Firm
- Galenus Mannheim 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
- 62 C - S 39 Methyldopate HCl (Anti-Hypertensive), Active Pharm Ingred/Chems for Further Manuf | 63 F - S 06 Digoxin (Cardiotonic), Active Pharm Ingred/Chems for Further Manuf | 65 Q - S 21 Metaxalone (Relaxant), Active Pharm Ingred/Chems for Further Manuf each item verified
- Product
- Methyldopa | Digoxin | Metaxalone each item verified
- FDA notes
- 11/2/2000 | 11/2/2000 | 11/2/2000 each item verified
What the source says
Galenus Mannheim 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.
Product code, Product and FDA notes
62 C - S 39 Methyldopate HCl (Anti-Hypertensive), Active Pharm Ingred/Chems for Further Manuf Date Published: 03/27/2019 Desc: Methyldopa Notes: 11/2/2000 63 F - S 06 Digoxin (Cardiotonic), Active Pharm Ingred/Chems for Further Manuf Date Published: 03/27/2019 Desc: Digoxin Notes: 11/2/2000 65 Q - S 21 Metaxalone (Relaxant), Active Pharm Ingred/Chems for Further Manuf Date Published: 03/27/2019 Desc: Metaxalone Notes: 11/2/2000
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_202.html