Refusal Actions by FDA as Recorded in OASIS for Germany
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Steierl-Pharma GmbH
Herrsching , DE ATL-DO XXX-0149189-4/1/1A
66VCY99 (Phyto-Hypophyson C) liquid medicines in glass bottles
01-AUG-2008 NO ENGLISH
Katjes Fassin Gmbh+Co. Kg
Emmerich/Rhein , DE 4040 BLT-DO BUQ-0405071-4/8/1
33LDT07 SKU#387963 CANDY SOFT KATJES TROPICAL LICORICE 200G
06-AUG-2008 UNSAFE COL
Katjes Fassin Gmbh+Co. Kg
Emmerich/Rhein , DE 4040 BLT-DO BUQ-0405071-4/20/1
33LDT07 SKU#387963 CANDY SOFT KATJES TROPICAL LICORICE 200G
06-AUG-2008 UNSAFE COL
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NOL-DO 112-3713161-3/1/1
53CK-02 864296932391/COSMETIC LIPLINERS/.01OZ
06-AUG-2008 CSTIC LBLG
COSMETLBLG
Mikrogen Gmbh
Neurled , DE NOL-DO 112-3761740-5/1/1
88L--DT 865692983100 recomBlot Treponema IgG
06-AUG-2008 NOT LISTED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064035-5/1/1
80F--OS CATHETERS
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064258-3/1/1
80F--OS CATHETERS
11-AUG-2008 REGISTERED
Conseil De L'Europe
Strasbourg , FR 67081 FLA-DO BOY-0000908-1/2/1
66VIS99 FORMYFOLIC ACID FOR REVIEW & RESEND TO BRAZIL/NOT FOR CONSUM
12-AUG-2008 UNAPPROVED
Godecke Gmbh
Frieburg , DE SAN-DO 112-3878754-6/2/1
61JDC08 860766218280 LIPITOR
14-AUG-2008 NOT LISTED
Clariant Produtke (Deutschland)
Frankfurt , DE 65926 NYK-DO 916-1723505-5/1/1
66YBS99 POLYGLYKOL 3350 PSB CAS# 25322-68-3
14-AUG-2008 DIRECTIONS
Clariant Produtke (Deutschland)
Frankfurt , DE 65926 NYK-DO 916-1765963-5/1/1
66YBS99 POLYGLYKOL 3350 PSB CAS# 25322-68-3
14-AUG-2008 DIRECTIONS
Franz Kalff Gmbh Vliesstoff-Fabrik
Euskirchen , DE 53881 ATL-DO 336-8804670-8/39/1
79L--RR KIT, FIRST AID;;
19-AUG-2008 NOT LISTED
Lipoid Kg
Ludwigshafen/Rhein , DE 6700 NYK-DO 112-4037995-1/1/1
55RP-99 790557951830 LECITHIN SOYBEAN POWDER
20-AUG-2008 EXPIRED
Merck Kgaa
Darmstadt , DE 64293 NYK-DO 101-7869806-3/1/1
63XAS64 MEGLUMINE LOW IN ENDOTO(NDA PRIOR 1998 ALREADY REVIEWED BY A
21-AUG-2008 DIRECTIONS
Merck Kgaa
Darmstadt , DE 64293 NYK-DO 101-7869851-9/2/1
63XAS64 MEGLUMINE LOW IN ENDOTOXINS(NDA PRIOR 1998 ALREADY REVIEWED
21-AUG-2008 DIRECTIONS
American Dental Systems
Vaterstatten , DE D85591 NOL-DO 112-1824266-0/1/1
76E--LW 951326967167 MATERIAL
22-AUG-2008 NOT LISTED
Wilhelm Meyer
Vlotho , DE NOL-DO 112-1499937-0/1/1
89I--OR 853041176058.WHEEL CHAIR
22-AUG-2008 NOT LISTED
Sasol Germany GmbH
Witten , DE 58453 LOS-DO BXE-0009828-3/1/1
56BKS52 IMWITOR 988 NON HUMAN USE
22-AUG-2008 UNAPPROVED
E. DENK OHG
Muenchen , DE FLA-DO 112-4007728-2/2/1
66VIP99 865811143081/NIFED DENK 10MG
25-AUG-2008 UNAPPROVED