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
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 LOS-DO 004-5008397-7/1/1
64XBJ06 Acne Treatment Concealer per actual product
05-JUN-2008 NOT LISTED
FALSE
AstraZeneca GmbH
Plankstadt , DE 68723 FLA-DO 112-2875491-0/1/1
61BCB04 860756042532+CASODEX
06-JUN-2008 UNAPPROVED
Bip Biomed.Instr.&Prod.Gmbh
Turkenfeld ~B Furstenfeldbru , DE 82299 NYK-DO EG6-1462106-8/1/1
78K--NW VACUFLASH BIOPSY SYSTEM
09-JUN-2008 NOT LISTED
REGISTERED
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NYK-DO M76-6096634-3/15/1
53CK-02 PRO PENCILS (COSTUME MAKEUP - EYE LINERS)
09-JUN-2008 COSMETLBLG
Mbe0004
Wesel , DE 46483 CIN-DO UPS-1085343-8/1/1
66VCK99 AMBENE, PARENTERAL, FOR INJECTION, FOR ID, PER USE
09-JUN-2008 DRUG GMPS
UNAPPROVED
Mbe0004
Wesel , DE 46483 CIN-DO UPS-1085343-8/1/2
66VCK99 DEXABENE, FOR INJECTION, FOR ID, PER USE
09-JUN-2008 DRUG GMPS
UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1A
56BJZ07 Ampicillin-T
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1B
56BJZ07 Ampicillin-T
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1C
88N--YA Adenosan (IgA, IgG, IgM)
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1D
68ACE20 Adenosan (IgA, IgG, IgM)
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1E
68BCE20 Chevicol+ (trichomonas treatment)
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1F
68BCE20 Chevicol+ (trichomonas treatment)
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1G
67B--03 Chevi-kok (amprolium)
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1H
66YPK99 Chevi-san (butaphosphane)
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1I
56EKE10 "Chlortetracyclin+"
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1J
56EKR10 "Chlortetracyclin+"
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1K
67C--25 furazolidon+
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1L
67C--25 furazolidon+
10-JUN-2008 UNAPPROVED
Chevita Gmbh
Pfaffenhofen , DE 85266 LOS-DO 190-4031505-3/1/1M
67C--61 Tylosin +chlortetracycline
10-JUN-2008 UNAPPROVED
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NOL-DO 112-2578310-2/1/1
53RY-03 957338302603/COSMETIC PENCILS
11-JUN-2008 COSMETLBLG
Paul Hartmann AG
Heidenheim An Der Brenz , DE 89522 LOS-DO 112-2196628-9/120/1
79L--RR FIRST AID KITS
11-JUN-2008 REGISTERED
Vdw Endontics Synergy
Munchen , DE SWI-DO GH5-0037753-2/1/1
76E--KL SPREADERS OBRUATION
16-JUN-2008 NOT LISTED
REGISTERED
Vdw Endontics Synergy
Munchen , DE SWI-DO GH5-0037753-2/2/1
76D--ZA DRILL
16-JUN-2008 NOT LISTED
REGISTERED
Vdw Endontics Synergy
Munchen , DE SWI-DO GH5-0037753-2/3/1
76E--KN SPREADERS OBRUATION
16-JUN-2008 NOT LISTED
REGISTERED
Vdw Endontics Synergy
Munchen , DE SWI-DO GH5-0037753-2/4/1
76E--AX MOUTH MIRROR
16-JUN-2008 NOT LISTED
REGISTERED
Vdw Endontics Synergy
Munchen , DE SWI-DO GH5-0037753-2/5/1
76E--MR DENTAL BURS AND FILES
16-JUN-2008 NOT LISTED
REGISTERED
Vdw Endontics Synergy
Munchen , DE SWI-DO GH5-0037753-2/7/1
76E--KN POINTERS
16-JUN-2008 NOT LISTED
REGISTERED
Lebkuchen-Schmidt Gmbh
Nurnberg , DE 90469 NOL-DO 112-3098886-0/1/1
03JGT10 863225879056 Heart-shaped Gingerbread cookiesd
17-JUN-2008 LIST INGRE
NO ENGLISH
USUAL NAME
LABELING
Chromsystems Gmbh
Munchen , DE 81243 NOL-DO 112-3110894-8/1/1
82D--GQ 939997670277 Immunosuppressants Whole Blood Control
17-JUN-2008 NOT LISTED
Burnus Gmbh
Darnstadt , DE D6100 MIN-DO 399-0933237-9/8/1C
66VBL99 Glysolid - Body Lotion
17-JUN-2008 UNAPPROVED
Sanofi-Aventis Deutschland Gmbh
Frankfurtfrankfurt , DE 65926 CIN-DO UPS-1167703-4/1/3
61NCA55 SULPIRIDE 50MG, NO RX, NO ID
18-JUN-2008 UNAPPROVED
Sanofi-Aventis Deutschland Gmbh
Frankfurtfrankfurt , DE 65926 CIN-DO UPS-1167703-4/1/7
61TCA12 METOCLOPRAMIDEHEDROCHLORIDE 10MG, NO RX, NO ID
18-JUN-2008 UNAPPROVED
Sanofi-Aventis Deutschland Gmbh
Frankfurtfrankfurt , DE 65926 CIN-DO UPS-1167703-4/1/8
61TCA12 METOCLOPRAMIDEHYDROCHLORIDE 5 MG, NO RX, NO ID
18-JUN-2008 UNAPPROVED
Oraltronics Gmbh
Bremen , DE NOL-DO 112-3154820-0/3/1
76N--HA 942525015961-ABUTMENT FOR DENTAL IMPLANT
19-JUN-2008 NOT LISTED
Kade Pharmaceytical
Berlin , DE NOL-DO 112-2912708-2/1/1
64LCO37 862420149603/POSTERISAN/LIDOCAINE
23-JUN-2008 UNAPPROVED
Zlb Gmbh
Springe , DE NOL-DO 112-2951187-1/1/1
57DJ-07 864258530802/HAEMOCOMPLETTAN
24-JUN-2008 NO LICENSE
Laetus Gmbh
Alsbach , DE 06146 0 NOL-DO 112-2914887-2/2/1
95R--DZ 859043407620 DIPLAY COMPLETE
24-JUN-2008 NO REGISTR
Cassella-Med Gmbh & Co Kg
Koln , DE 50670 NOL-DO 112-2954463-3/1/1
66VIP99 860790254721 LIPOSTABIL 5ML
24-JUN-2008 UNAPPROVED
Physo-M Punkt
Haibach , DE 63808 LOS-DO ACV-0005581-2/1/1
89N--GX BODYFORMER 20+4 I-TRAINER
25-JUN-2008 NO 510(K)
Guebert Gmbh
Sulzbach , DE 65843 NOL-DO 112-1379128-1/1/1
66VIP99 860635155030/PATENBLAU/2ML
30-JUN-2008 UNAPPROVED
Schenker Deutschland Ag
Berlin , DE 14055 NOL-DO 112-1401079-8/2/1
65JDB39 857876198904 YASMIN 1 MG
30-JUN-2008 UNAPPROVED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/19/1
76E--IF NOBELRONDO AL TRANSPA CLEAR 20 G
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/23/1
76E--IF NOBELRONDO ZIRCONIA DENTIN B3 SC 100G
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/31/1
76E--IF NOBELRONDO ZIRCONIA DENTIN A0 SB 20 G
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/37/1
76E--IF NOBELRONDO AL DENTIN A0 SB 20 G
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/58/1
76E--IF NOBELRONDO ZIRCONIA TRANSPA OPAL 20 G
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/64/1
76E--IF SHANK 1:1
30-JUN-2008 NOT LISTED
REGISTERED
W & H DentalWerk Buermoos GMBH
Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/3/1
76E--IF SET OF SPRAY TUBES, DISPOSABLE.
30-JUN-2008 NOT LISTED
NO 510(K)
W & H DentalWerk Buermoos GMBH
Burmoos SBG, AT 5111 LOS-DO 336-6589782-6/5/1
76E--IF SET OF SPRAY TUBES, DISPOSABLE.
30-JUN-2008 NOT LISTED
NO 510(K)