Refusal Actions by FDA as Recorded in OASIS for Dominican Republic
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Emmanuel Evans Scott
Santo Domingo , DO FLA-DO JN8-0014137-4/1/1
28CHT51 VANILLA EXTRACT (SAMPLES W/OUT COMMERCIAL VALUE NOT FOR RESA
05-JUN-2008 COUMARIN
Sabana Larga Farms S A
Dajabon , DO FLA-DO HG8-0117666-7/6/1
24FFC06 SQUASH
13-JUN-2008 PESTICIDE
Antonio Ramon Taveras Agroindustrial CA
Moca Espaillat, DO 56000 NYK-DO 176-0062730-5/4/1
21XGC14 TAMARINDS
13-JUN-2008 FILTHY
Laboratorio Capilo C Por A
Santo Domingo , DO FLA-DO M21-0737695-8/13/1B
53LD-09 12 bottles Romero Rosemary Oil / 12 bottles Almendra Almond
17-JUN-2008 COSM COLOR
LABELING
Laboratorio Capilo C Por A
Santo Domingo , DO FLA-DO M21-0737695-8/13/1C
61WBL36 Capilo - Nail Fungus Treatment
17-JUN-2008 WARNINGS
LABELING
UNAPPROVED
INDO- PHARMA, S.A.
SANTO DOMINGO , DO FLA-DO M21-0737695-8/25/1
54YCL99 100 pcs. 3ml-SOLADEK-N / 500 pcs. 5ml-SOLADEK
17-JUN-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO M21-0737695-8/27/3
62WBR99 BORASOL - Antiseptic Powder (antinflammatory)
17-JUN-2008 UNAPPROVED
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO M21-0737695-8/27/1
64HBL99 Sancochito - Dr. Collado Anticatarral Expectorante
17-JUN-2008 UNAPPROVED
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO M21-0737695-8/27/2
64HBL99 Jarabe De Gomenol - Dr. Collado Anticatarral Y Expectorante
17-JUN-2008 UNAPPROVED
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO M21-0737695-8/27/6
54YCL99 Helena Valle - Vegetable Compound - Antispasmodic and Uterin
17-JUN-2008 DIETARYLBL
NUTRIT LBL
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO M21-0737695-8/28/1
61HBU99 Dr. Collado - Germicidal Soap - Antimicrobial skin cleanser
17-JUN-2008 NO ENGLISH
UNAPPROVED
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO M21-0737695-8/30/1
62MBJ01 UBRENAL - El Corral ( Anti-inflamitory)
17-JUN-2008 NO ENGLISH
UNAPPROVED
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO M21-0737695-8/31/1B
53LC-99 CONCHA - De Nacar Creama Aclarante
17-JUN-2008 CSTIC LBLG
Laboratorios Dr Collado Ca
Santo Domingo Dominican , DO NYK-DO 315-6189036-4/1/1A
66VAU99 Creolin soap
24-JUN-2008 NOT LISTED
DIRECTIONS
UNAPPROVED
Laboratorios Dr Collado Ca
Santo Domingo Dominican , DO NYK-DO 315-6189036-4/1/1B
66VAU99 Sulfur soap
24-JUN-2008 NOT LISTED
DIRECTIONS
UNAPPROVED
Laboratorios Dr Collado Ca
Santo Domingo Dominican , DO NYK-DO 315-6189036-4/4/1B
66VDL99 Malt Extract with Hemoglobin
24-JUN-2008 DIRECTIONS
UNAPPROVED
Alopecil Corporation C X A
Santo Domingo , DO NYK-DO 315-6189036-4/6/1A
66VCS99 Septicon
24-JUN-2008 NOT LISTED
DIRECTIONS
UNAPPROVED
Consorcio Citiricos Dominicanos C Por A
Villa Altagracia , DO FLA-DO MQ7-0023057-5/1/1
30GEF99 COCONUT MILK
25-JUN-2008 NO PROCESS
Consorcio Citiricos Dominicanos C Por A
Villa Altagracia , DO FLA-DO MQ7-0023121-9/1/1
30GEF99 COCONUT MILK
25-JUN-2008 NO PROCESS
Exportadora Domingo Alvarez, S.A.
Santo Domingo , DO PHI-DO 176-0063384-0/6/1
21SHC14 TAMARINDS
26-JUN-2008 FILTHY
Proyecto Gomez Araguez
Santiago , DO FLA-DO D97-0454674-3/1/1
16EGD06 FROZEN CONCH
27-JUN-2008 FILTHY
Ana Hidalgo
Puerto Plata , DO NOL-DO 112-1259377-9/1/1
54ABA12 864083437052 Folimen 5 mg, calcibon natal, natele
27-JUN-2008 NO ENGLISH
Ethical Pharmaceutical
Santo Domingo , DO NOL-DO 112-1259377-9/2/1
61TCA11 864083437052 Hipermex
27-JUN-2008 UNAPPROVED
Ucb S.A. Pharma Sector
B-1420 Braine-L'Aleud , BE NOL-DO 112-1259377-9/3/1
61TQA11 864083437052 NAVIDOXINE (MECLIZINE HCl)
27-JUN-2008 UNAPPROVED
Copey Products Internacional
La Vega , DO NYK-DO 176-0063554-8/1/1
24FGB07 SWEET PEPPERS (TO BE TAKEN TO PRIVATE LAB)
30-JUN-2008 PESTICIDE