Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3006891884
Manufacturer Name: Baganovo
Manufacturer address line 1: 40 Gloucester Rd
Manufacturer address line 2:
Manufacturer City: Barnet
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 62ACK05
Importers product description: ZOMETA
Refusal date: 10-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: DO7-8719848-3/1/1/
Carrier: ICELANDAIR
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED
Manufacturer FEI: 3007027341
Manufacturer Name: Union Trading Co L
Manufacturer address line 1: 1101 6 New City
Manufacturer address line 2:
Manufacturer City: Nanjing
Manufacturer Province/state:
Manufacturer Country: China
Product code: 62CBY41
Importers product description: 865126307704 MINOXIDIL SULPHATE
Refusal date: 18-JUL-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-3575140-4/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
UNAPPROVED
Manufacturer FEI: 3007042279
Manufacturer Name: Ecosol Ag
Manufacturer address line 1: Hinterbergstrasse 24
Manufacturer address line 2:
Manufacturer City: Cham
Manufacturer Province/state:
Manufacturer Country: Switzerland
Product code: 62CDA65
Importers product description: 847067944313 LISINOPRIL 5MG
Refusal date: 25-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3716516-5/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006036290
Manufacturer Name: Amdipharm
Manufacturer address line 1: Regency House Miles Gray Rd
Manufacturer address line 2:
Manufacturer City: Essex
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 62CDZ22
Importers product description: 924192468654 GUANETHIDINE MONOSULPHATE
Refusal date: 31-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3160469-8/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED
Manufacturer FEI: 3006094247
Manufacturer Name: Research Pharmaceutical Co Ltd
Manufacturer address line 1: 58 Xiangcheng Rd
Manufacturer address line 2:
Manufacturer City: Shanghai
Manufacturer Province/state:
Manufacturer Country: China
Product code: 62FAA34
Importers product description: POVIDONE IODINE "FOR EXPORT ONLY" PLEASE REFUSE THE MERCHAND
Refusal date: 14-JUL-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0737782-4/2/1/
Carrier: CHINA SHIPPING CONTAINER LINE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005289584
Manufacturer Name: Schering-Plough House
Manufacturer address line 1: Falcon Way
Manufacturer address line 2:
Manufacturer City: Welwyn Garden
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 62FAK53
Importers product description: 864093171473/NASONEX
Refusal date: 21-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3498215-8/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 2000010255
Manufacturer Name: Moskovksaya Pharmfabrika
Manufacturer address line 1: Farmatsevtichesky Proezd 1
Manufacturer address line 2:
Manufacturer City: Moscow
Manufacturer Province/state: RU-MOS
Manufacturer Country: Russia
Product code: 62FAY99
Importers product description: STREPTOCIDE POWDER
Refusal date: 24-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: BQL-0012565-6/42/1/
Carrier: CHINA SHIPPING CONTAINER LINE
Bill of Lading: CHNJPBNYC650
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
Manufacturer FEI: 2000010255
Manufacturer Name: Moskovksaya Pharmfabrika
Manufacturer address line 1: Farmatsevtichesky Proezd 1
Manufacturer address line 2:
Manufacturer City: Moscow
Manufacturer Province/state: RU-MOS
Manufacturer Country: Russia
Product code: 62FAY99
Importers product description: STREPTOCIDE OINTMENT
Refusal date: 24-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: BQL-0012565-6/42/2/
Carrier: CHINA SHIPPING CONTAINER LINE
Bill of Lading: CHNJPBNYC650
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006984013
Manufacturer Name: Sherring
Manufacturer address line 1: In
Manufacturer address line 2:
Manufacturer City: Argentina
Manufacturer Province/state:
Manufacturer Country: Argentina
Product code: 62GAO99
Importers product description: 865717903876/SCHEDERMA
Refusal date: 23-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3143485-6/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004452413
Manufacturer Name: Remedica Ltd
Manufacturer address line 1: Industrial East P.o. Box 51706
Manufacturer address line 2:
Manufacturer City: Limassol
Manufacturer Province/state:
Manufacturer Country: Cyprus
Product code: 62GAO99
Importers product description: 865717903876/VULTARIN
Refusal date: 23-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3143485-6/3/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006230648
Manufacturer Name: Marksans Pharma Limited
Manufacturer address line 1: Plot No. L-82, L-83
Manufacturer address line 2: Verna Industrial Estate
Manufacturer City: Verna, Goa
Manufacturer Province/state:
Manufacturer Country: India
Product code: 62GCH41
Importers product description: 957577448130 IBUPROFEN SOFT GET CAPS
Refusal date: 15-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 112-3212739-2/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006812683
Manufacturer Name: Nuvo Manufacturing
Manufacturer address line 1: 3855 Chemin De La Cotr Bissonnet
Manufacturer address line 2:
Manufacturer City: Varennes
Manufacturer Province/state: QUEBEC
Manufacturer Country: Canada
Product code: 62GCL18
Importers product description: 799866792342 PENNSAID TOPICAL
Refusal date: 07-JUL-2008
FDA_District: DET-DO
Entry/doc/line/sfx: 112-3164999-0/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006293869
Manufacturer Name: Novartis
Manufacturer address line 1: Cra 8 N 12 38
Manufacturer address line 2:
Manufacturer City: Bogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 62GCY90
Importers product description: 969315191690 VOLTAREN
Refusal date: 30-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3161476-2/1/4/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3003699941
Manufacturer Name: Cipla Ltd
Manufacturer address line 1: Mumbai Central
Manufacturer address line 2:
Manufacturer City: Mumbai
Manufacturer Province/state:
Manufacturer Country: India
Product code: 62GDJ18
Importers product description: 865717903876/OMNIGEL
Refusal date: 23-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3143485-6/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3001258572
Manufacturer Name: Rhenochem Ag
Manufacturer address line 1: 4011
Manufacturer address line 2:
Manufacturer City: Basel
Manufacturer Province/state:
Manufacturer Country: Switzerland
Product code: 62GDL18
Importers product description: DICLOFENAC SODIUM 75MG "FOR EXPORT ONLY" PLEASE REFUSE MERCH
Refusal date: 14-JUL-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0737763-4/3/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006806545
Manufacturer Name: Werthenstein Chemie A.S.
Manufacturer address line 1: Ch-6105
Manufacturer address line 2:
Manufacturer City: Schachen
Manufacturer Province/state:
Manufacturer Country: Switzerland
Product code: 62GIP99
Importers product description: BIOTHERAPEUTIC ANTIBODY FOR CLINICAL STUDY/NON-HUMAN USE
Refusal date: 19-JUL-2008
FDA_District: SAN-DO
Entry/doc/line/sfx: 607-5330968-5/1/1/
Carrier: LUFTHANSA CARGO AG
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED
Manufacturer FEI: 3006406107
Manufacturer Name: Kylolab Srl
Manufacturer address line 1: Rio Guadalentin13
Manufacturer address line 2:
Manufacturer City: Ceuti
Manufacturer Province/state:
Manufacturer Country: Spain
Product code: 62IAS13
Importers product description: CHLORAMBUCIL
Refusal date: 01-JUL-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: 906-0648899-8/1/1/
Carrier: KLM ROYAL DUTCH AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3007020912
Manufacturer Name: C Y Huang
Manufacturer address line 1: 8f No 245sec 1 Dun Hua S Rd
Manufacturer address line 2:
Manufacturer City: Taipeitaipei
Manufacturer Province/state:
Manufacturer Country: Taiwan
Product code: 62KCA10
Importers product description: OMEPRAZOLE/NO RX/NO ID/PER USE
Refusal date: 30-JUL-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-1676643-6/1/1/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006804339
Manufacturer Name: PZ Nigeria Limited
Manufacturer address line 1: 45/47 Town Planning Way
Manufacturer address line 2: Ilupeju
Manufacturer City: Lagos
Manufacturer Province/state: Ng-La
Manufacturer Country: Nigeria
Product code: 62MBJ01
Importers product description: ROBB
Refusal date: 07-JUL-2008
FDA_District: SWI-DO
Entry/doc/line/sfx: XXX-0154239-9/1/1/F
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
UNAPPROVED
Manufacturer FEI: 3004287224
Manufacturer Name: Ravi Spice Processors Pvt. Ltd.
Manufacturer address line 1: No. 60 Hill View Building
Manufacturer address line 2: Mysore Road, Nayanadhalli
Manufacturer City: Bangalore
Manufacturer Province/state: In-Ka
Manufacturer Country: India
Product code: 62MBJ08
Importers product description: VAPORUB
Refusal date: 08-JUL-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 429-0842225-8/41/1/A
Carrier: NYK LINE (NIPPON YUSEN KAISHA
Bill of Lading: NYKS26016931
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
DRUG NAME
N-RX INACT
Manufacturer FEI: 3006991528
Manufacturer Name: Distribution Lhebert
Manufacturer address line 1: 15260 Notre Dame Est Qc
Manufacturer address line 2:
Manufacturer City: Montreal
Manufacturer Province/state: QUEBEC
Manufacturer Country: Canada
Product code: 62MOO08
Importers product description: MENTHOL BASED ANALGESIC CREAM SOLD TO US CITIZEN
Refusal date: 23-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 310-1318743-6/1/1/
Carrier: PUROLATOR COURIER LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3004742797
Manufacturer Name: Pfizer Phils
Manufacturer address line 1: 23 Ayala Avenue
Manufacturer address line 2:
Manufacturer City: Makati City
Manufacturer Province/state:
Manufacturer Country: Philippines
Product code: 62OCA24
Importers product description: 848082203067 DILTIAZEM
Refusal date: 10-JUL-2008
FDA_District: SAN-DO
Entry/doc/line/sfx: 112-3098065-1/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3007017698
Manufacturer Name: Rabia Mansoor
Manufacturer address line 1: 1 Bradford Rd
Manufacturer address line 2:
Manufacturer City: Bedfrodview
Manufacturer Province/state:
Manufacturer Country: South Africa
Product code: 62OCF11
Importers product description: TRANDOLAPRIEL
Refusal date: 18-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: AEK-9123029-8/1/1/
Carrier: VIRGIN ATLANTIC AIRWAYS LTD.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED
Manufacturer FEI: 3003585876
Manufacturer Name: Shasun Chemicals and Drugs, Ltd.
Manufacturer address line 1: A 1/B Spicot Industrial Complex
Manufacturer address line 2: Kudikadu Village
Manufacturer City: Cuddalore
Manufacturer Province/state:
Manufacturer Country: India
Product code: 62OCS38
Importers product description: Isradipine; NDC# 57910-023-00; A/NDA# 20-336
Refusal date: 23-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: MC2-6068907-0/1/1/
Carrier: Etihad Airways
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
Manufacturer FEI: 3004751734
Manufacturer Name: Vianex Ae L
Manufacturer address line 1: 146 10 N Erythraia N
Manufacturer address line 2:
Manufacturer City: Trithraia
Manufacturer Province/state:
Manufacturer Country: Greece
Product code: 62ODB28
Importers product description: 865352052296/RENITEC
Refusal date: 21-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3476153-7/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005300303
Manufacturer Name: Sandoz Agro Canada Inc
Manufacturer address line 1: 2000 Argentia Rd Ste 302
Manufacturer address line 2:
Manufacturer City: Mississauga
Manufacturer Province/state: ON
Manufacturer Country: Canada
Product code: 62VCB25
Importers product description: FANCICLOVIR/PENICLOVIR
Refusal date: 21-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3493403-5/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005040859
Manufacturer Name: Body Blue Incorporated
Manufacturer address line 1: 2300 Drew Road
Manufacturer address line 2:
Manufacturer City: Mississauga
Manufacturer Province/state: ON
Manufacturer Country: Canada
Product code: 62WAJ99
Importers product description: ANTIPERSPIRANT/DEODORANT
Refusal date: 03-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 300-2548306-4/1/1/
Carrier: INTERNATIONAL TRUCKLOAD SERVI
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
FALSE
Manufacturer FEI: 3005135849
Manufacturer Name: Bio Care Ltd
Manufacturer address line 1: Lakeside, 180 Lifford Lane
Manufacturer address line 2:
Manufacturer City: Birmingham
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 62WAJ99
Importers product description: 714393564532 Cervagyn cream
Refusal date: 30-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3130373-9/1/1/B
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
DR QUALITC
Manufacturer FEI: 3002512569
Manufacturer Name: Metabolics Ltd
Manufacturer address line 1: 5 Eastcott Common
Manufacturer address line 2:
Manufacturer City: Devizes
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 62WAJ99
Importers product description: 714393564532 VAGINAL CREAM
Refusal date: 31-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3130373-9/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
DR QUALITC
Manufacturer FEI: 3002712501
Manufacturer Name: Bourjois Parfume Paris
Manufacturer address line 1: 12-14 Rue Victor Noir
Manufacturer address line 2:
Manufacturer City: Neuilly Sur Seine
Manufacturer Province/state:
Manufacturer Country: France
Product code: 62WBY17
Importers product description: DEODORANTS/ ANTIPERS
Refusal date: 14-JUL-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 408-1169503-7/4/1/
Carrier: AIR FRANCE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005040859
Manufacturer Name: Body Blue Incorporated
Manufacturer address line 1: 2300 Drew Road
Manufacturer address line 2:
Manufacturer City: Mississauga
Manufacturer Province/state: ON
Manufacturer Country: Canada
Product code: 62WBY99
Importers product description: SECRET ANTIPERSPIRANT
Refusal date: 03-JUL-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 300-2547784-3/2/1/
Carrier: INTERNATIONAL TRUCKLOAD SERVI
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): FALSE