Reference Source

Galenus Mannheim · 66-66 · GERMANY

For Galenus Mannheim · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

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

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

Source

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