Refusal Actions by FDA as Recorded in OASIS
Country of Origin Entry # DOC Line Suffix
Manufacture Name
City / Country or region District
Product Code Product Description
Date Reason
India 112-1928713-6 1 1
Inga Pharceuticals, Inga House
Mumbai, Andheri , IN 400093 NOL-DO
61AIS09 738192012022/EMETINE
04-APR-2008 NOT LISTED
UNAPPROVED
Switzerland M21-0737548-9 1 1
Chemo S.A. Lugano Branch
Lugano , CH FLA-DO
61EAA08 DESLORATADINE FOR EXPORT ONLY "PLEASE REFUSE CARGO"
03-APR-2008 UNAPPROVED
India M21-0737571-1 1 1
Research Pharmaceutical
Bogota , CO FLA-DO
61EAA08 LORATADINE FOR EXPORT ONLY, PLEASE REFUSE CARGO
18-APR-2008 UNAPPROVED
Switzerland M21-0737575-2 2 1
Rhenochem Ag
Basel , CH FLA-DO
61FAE53 CEFADROXIL MONOHYDRATE FOR EXPORT ONLY (PLEASE REFUSE MERCHA
15-APR-2008 NOT LISTED
United Kingdom 946-0605101-2 210 1
Reckitt Benkiser Ltd
Swindon , GB SN57XZ LOS-DO
61FKK21 DETTOL ANTISEPTIC / DISINFECTANT LIQUID 12/250ML
19-APR-2008 NOT LISTED
Canada 112-1583324-8 1 1
Leo Pharma Inc
Thornhill NEWFOUNDLAND, CA L3T7W8 DET-DO
61HDO99 Fucidin H Cream
10-APR-2008 UNAPPROVED
Germany 112-1944504-9 1 1
Pfizer
Berlin , DE NOL-DO
61JDA08 948125020453/LIPITOR 20MG
08-APR-2008 UNAPPROVED
United States UPS-0711557-7 1 4
Ups Rts-Old Trk 1z2x25086645675914
Parmaparma , IT 43100 NYK-DO
61NCB05 US GOODS BEING RET'D-WELLBUTRIN
22-APR-2008 AGR RX
Iran AEK-9091995-8 1 1
Mehdi Taheri
Tehran , IR NYK-DO
61NCE29 FLUOXETINE
16-APR-2008 UNAPPROVED
Switzerland M21-0737575-2 1 1
Rhenochem Ag
Basel , CH FLA-DO
61NDB76 PAROXETINE TABLETS 20MG "FOR EXPORT ONLY" PLEASE REFUSE MERC
15-APR-2008 NOT LISTED
Canada 551-7589552-8 1 1
Pharmascience Inc.
Montreal QC, CA H4P2T4 NYK-DO
61NQR69 Bulk Gabapentin
17-APR-2008 UNAPPROVED
Canada XXX-0153624-3 1 1
Servier Research & Pharmaceutica
Lahore , PK MIN-DO
61PCC99 Diamicron (Gliclazide) Canadian Prescription Drug
01-APR-2008 UNAPPROVED
Canada XXX-0153624-3 1 2
Servier Research & Pharmaceutica
Lahore , PK MIN-DO
61PCC99 Blutab Rosiglitazone
01-APR-2008 UNAPPROVED
India M21-0737539-8 1 1
Granules India Limited
Hyderabad , IN FLA-DO
61PCS55 METFORMIN FOR EXPORT ONLY(PLEASE REFUSE CARGO)
11-APR-2008 UNAPPROVED
Israel 112-1776568-7 1 2
Vitamed Inc
Binyamina , IL NOL-DO
61XCB45 862022627431/CETRIN 10MG
09-APR-2008 UNAPPROVED