Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3005286372
Manufacturer Name: Zuoz Pharma Sa Pre
Manufacturer address line 1: Puente Restaurador A Rio Ave
Manufacturer address line 2:
Manufacturer City: Caracas
Manufacturer Province/state:
Manufacturer Country: Venezuela
Product code: 60CAB49
Importers product description: 929420391000/MUCORAMA
Refusal date: 11-JUN-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3011092-9/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3002703905
Manufacturer Name: Medex Scientific
Manufacturer address line 1: 4 Denne Road
Manufacturer address line 2:
Manufacturer City: Horsham W Sus
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 60CAY99
Importers product description: 843704744924 SLIMMING PATCHES
Refusal date: 11-JUN-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2912452-7/1/1/
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: 3004866307
Manufacturer Name: Arlex Mexico, S.A. de C.V.
Manufacturer address line 1: Puerto Acapulco
Manufacturer address line 2: No. 35 Col. Piloto
Manufacturer City: Piloto
Manufacturer Province/state:
Manufacturer Country: Mexico
Product code: 60LAB01
Importers product description: 863356008888 CRIPOFEN
Refusal date: 11-JUN-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3070837-5/2/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005440006
Manufacturer Name: Biomep Sa De Sv
Manufacturer address line 1: Providencia No 662
Manufacturer address line 2:
Manufacturer City: Mexico
Manufacturer Province/state:
Manufacturer Country: Mexico
Product code: 60LAB21
Importers product description: 863356008888 DIPYRONE
Refusal date: 11-JUN-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3070837-5/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3002968666
Manufacturer Name: Foreign Trade Zone#202-A3m Pharmaceuticals
Manufacturer address line 1: 19901 Nordoff Streetbox 1
Manufacturer address line 2:
Manufacturer City: Northridge
Manufacturer Province/state: CA
Manufacturer Country: United States
Product code: 60LBA08
Importers product description: BENZYDAMINE HCL (ANALGESIC);HUMAN N/RX COMB INGR;PROMPT RELE
Refusal date: 05-JUN-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: 336-8064699-2/3/1/
Carrier: FTZ202A
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED
Manufacturer FEI: 3004144159
Manufacturer Name: Aspar Pharmaceuticals
Manufacturer address line 1: 29-30 Capitol Way
Manufacturer address line 2:
Manufacturer City: London
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 60LBB01
Importers product description: 864692562149 CO-CODAMOL
Refusal date: 30-JUN-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-1385405-5/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005195154
Manufacturer Name: Ups Oporto
Manufacturer address line 1: Complexo Carga Upsaeroporto Francisco Sa
Manufacturer address line 2:
Manufacturer City: Maiamaia
Manufacturer Province/state:
Manufacturer Country: Portugal
Product code: 60LCB85
Importers product description: US GOODS BEING RET'D-MEDICATION(ASACOL 400MG 270TABLETS)
Refusal date: 04-JUN-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: UPS-0596225-1/1/1/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): AGR RX
Manufacturer FEI: 3004537450
Manufacturer Name: Wyeth Consumer Hea
Manufacturer address line 1: 5975 Whittle Rd 4f
Manufacturer address line 2:
Manufacturer City: Mississauga
Manufacturer Province/state: ON
Manufacturer Country: Canada
Product code: 60LDA05
Importers product description: 928169657616/ ROBAXICET 400 MG
Refusal date: 19-JUN-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3117977-4/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006403771
Manufacturer Name: Jinan Cheng Hui-Shuangda Chemical LTd.
Manufacturer address line 1: Southern Section of Kai Tuo Road
Manufacturer address line 2: High-Technology Development Zone
Manufacturer City: Jinan
Manufacturer Province/state:
Manufacturer Country: China
Product code: 60QCA69
Importers product description: PRAMOXINE HYDROCHLORIDE FOR EXPORT ONLY, PLEASE REFUSE MERCH
Refusal date: 09-JUN-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0737751-9/1/1/
Carrier: KOREAN AIR LINES CO. INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005579246
Manufacturer Name: Hospira Inc.
Manufacturer address line 1: 375 N Field Dr
Manufacturer address line 2:
Manufacturer City: Lake Forest
Manufacturer Province/state: IL
Manufacturer Country: United States
Product code: 60QDK40
Importers product description: 1 %LIDOCAINE HCL INJECTION, USP
Refusal date: 24-JUN-2008
FDA_District: SWI-DO
Entry/doc/line/sfx: UPS-0043257-0/1/1/
Carrier: TRANSPORTES ESPECIALIZADOS DE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): AGR RX
Manufacturer FEI: 3006848055
Manufacturer Name: 3101466409 S.A. (Mbe)
Manufacturer address line 1: Frente A Plaza Atlantis, Escazu
Manufacturer address line 2:
Manufacturer City: San Josesan Jose
Manufacturer Province/state:
Manufacturer Country: Costa Rica
Product code: 60RCA16
Importers product description: DUROMIN/NO RX/NO ID/PER USE
Refusal date: 10-JUN-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-1129133-1/1/1/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3003528951
Manufacturer Name: Sanofi Synthelabo
Manufacturer address line 1: 11 Rue De Veyrot
Manufacturer address line 2:
Manufacturer City: Meyrin
Manufacturer Province/state:
Manufacturer Country: Switzerland
Product code: 60SAA99
Importers product description: 852182831128/BIOFLORIN
Refusal date: 24-JUN-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3127915-2/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004985146
Manufacturer Name: Dabur International Limited
Manufacturer address line 1: P.O. Box 16944
Manufacturer address line 2:
Manufacturer City: Jebel Ali
Manufacturer Province/state:
Manufacturer Country: United Arab Emirates
Product code: 60SBL09
Importers product description: SAT ISABGOL
Refusal date: 19-JUN-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 300-1972695-7/1/1/
Carrier:
Bill of Lading: SAFM75054661
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3005374223
Manufacturer Name: Sanofi Aventia
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer City: Surrey
Manufacturer Province/state:
Manufacturer Country: United Kingdom
Product code: 60SCA23
Importers product description: METOCLOPRAMIDE 20 MG, NO RX, NO ID
Refusal date: 18-JUN-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-1167703-4/1/6/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005798963
Manufacturer Name: Medaire, Inc.
Manufacturer address line 1: 23610 N 20th Dr Ste 10
Manufacturer address line 2:
Manufacturer City: Phoenix
Manufacturer Province/state: AZ
Manufacturer Country: United States
Product code: 60XCA17
Importers product description: ATENOLOL (ANTI-ADRENERGIC);HUMAN - RX/SINGLE INGREDIENT;PROM
Refusal date: 25-JUN-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 462-0121215-9/1/2/
Carrier: BRITISH AIRWAYS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): AGR RX