Refusal Actions by FDA as Recorded in OASIS for Mexico
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Pakmail Boca Del Rio
Veracruzveracruz , MX 94298 CIN-DO 110-1502397-7/1/1
60XCA02 SERMETROL/NO RX/NO ID/PER USE
01-FEB-2008 UNAPPROVED
S&Y Mexico Corp S.A.
San Pedro Garcianuevo Leon , MX 66260 SWI-DO 144-8401941-1/1/1
63RBJ05 SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC);HUMA
01-FEB-2008 NOT LISTED
NO ENGLISH
S&Y Mexico Corp S.A.
San Pedro Garcianuevo Leon , MX 66260 SWI-DO 144-8401941-1/3/1
62UCA99 COUGH DROPS
01-FEB-2008 NO ENGLISH
S&Y Mexico Corp S.A.
San Pedro Garcianuevo Leon , MX 66260 SWI-DO 144-8401941-1/4/1
33UGT02 TRIDENT FRESHMINT CHEWING GUM
01-FEB-2008 NO ENGLISH
Chupa Chups Industrial Mexicana S.A. de C.V.
Toluca MX-NOTA, MX 50200 NYK-DO D03-0155667-2/4/1
33SGT06 LOLLIPOPS
04-FEB-2008 UNSAFE COL
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0009051-2/2/1
33HFT06 CANDY
05-FEB-2008 UNSAFE COL
PRODUCTOS LACTEOS ALVAMIX
CD. JUAREZ MX-CHH, MX 32280 SWI-DO U32-0011944-4/1/1
20AFD14 FROZEN STRAWBERRIES IN BOXES
05-FEB-2008 LIST INGRE
LACKS FIRM
LABELING
NUTRIT LBL
S&Y Mexico Corp S.A.
San Pedro Garcianuevo Leon , MX 66260 SWI-DO 144-8402036-9/1/1
63RBJ05 SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC);HUMA
05-FEB-2008 NOT LISTED
NO ENGLISH
Baja Agro International Sa De Cv
Ensenada Baja Califor FN, MX SWI-DO BLN-0015116-4/1/1
54FMR63 Yucca schidigera powder "Biopowder M"
05-FEB-2008 PESTICIDES
Baja Agro International Sa De Cv
Ensenada Baja Califor FN, MX SWI-DO BLN-0015273-3/1/1
54FMR63 YUCCA SCHIDIGERA DRY FIBER POWDER FOR ANIMAL FEED
05-FEB-2008 PESTICIDES
Baja Agro International Sa De Cv
Ensenada Baja Califor FN, MX SWI-DO BLN-0015104-0/1/1
54FMR63 Yucca schidigera powder "BIOPOWDER M"
05-FEB-2008 PESTICIDES
Baja Agro International Sa De Cv
Ensenada Baja Califor FN, MX SWI-DO BLN-0015274-1/1/1
54FMR63 YUCCA SCHIDIGERA DRY FIBER POWDER FOR ANIMAL FEED
05-FEB-2008 PESTICIDES
Laboratorios Sophias Sa De Cv
Guadalajara Jaliscomexico , MX 44290 CIN-DO 110-1475027-3/1/1
66VCL99 AMBROXOL, NO RX, FOR ID, PER USE
06-FEB-2008 UNAPPROVED
Schering-Plough S.A. De C.V.
Col Xaltocancol Xaltocan , MX 16090 CIN-DO 110-1475027-3/1/2
60CAL48 AFRIN LUB, NO RX, FOR ID, PER USE
06-FEB-2008 UNAPPROVED
Laboratorios Kendrick
Mexico , MX 05120 CIN-DO 110-1475027-3/1/3
61ECA08 LORATADINA, NO RX, FOR ID, PER USE
06-FEB-2008 UNAPPROVED
Laboratorios Alpharma
Mexico , MX 11610 CIN-DO 110-1475027-3/1/4
60LAA01 PARACETAMOL, NO RX, FOR ID, PER USE
06-FEB-2008 UNAPPROVED
Schering Plough Sa De Cv
Xochimilco, Mexico , MX 106090 CIN-DO 110-1475027-3/1/5
64GDA29 MICROGYNON, NO RX, FOR ID, PER USE
06-FEB-2008 UNAPPROVED
Vitae Laboratorios
Guadalajara , MX CIN-DO 110-1475027-3/1/6
62KCA10 ULTIZOL, NO RX, FOR ID, PER USE
06-FEB-2008 UNAPPROVED
Envios Y Empaques Sa De Cv
Mexico , MX 14370 CIN-DO 110-1475027-3/1/7
56KDL10 SOLDRIN, NO RX, FOR ID, PER USE
06-FEB-2008 UNAPPROVED
El Regimiento Spr De Rl
San Ixcuintla, Nay. , MX SWI-DO 699-1129954-8/3/1
24AFC14 BEANS GRN/CRTS
06-FEB-2008 FILTHY
Rafael Alvarado
Col San Angel , MX NOL-DO 112-0988898-4/2/1
53ED-99 862813504777 HAIR PREPARATION
06-FEB-2008 CSTIC LBLG
Mario Villa Hernandez
Michoacan MX-MIC, MX 60626 SWI-DO EFR-1001824-3/2/1
21SFC06 FRESH PAPAYA
06-FEB-2008 PESTICIDE
Mario Villa Hernandez
Michoacan MX-MIC, MX 60626 SWI-DO EFR-1001827-6/2/1
21SFC06 FRESH PAPAYA
06-FEB-2008 PESTICIDE
Productos Frescamar S.A. De C.V.
Ensenada Baja California Norte, MX 1234 SWI-DO N55-0135208-6/1/1
16MEE03 Imitation Abalone- prepared from calamari
06-FEB-2008 FILTHY
NUTRIT LBL
Ensambladores Electronicos De Mexico S A
Mexicali , MX FLA-DO 110-0875312-6/1/1
94V--07 14" MONITOR ASSY
07-FEB-2008 NON STD
Nails For You
Monterrey , MX NOL-DO 112-1241310-1/1/1
53HY-99 864737516024 FINISH WIPE
07-FEB-2008 COSM COLOR
CSTIC LBLG
Nails For You
Monterrey , MX NOL-DO 112-1241310-1/1/3
53HY-99 864737516024 NAIL LIQUID
07-FEB-2008 CSTIC LBLG
Nails For You
Monterrey , MX NOL-DO 112-1241310-1/1/4
53HY-99 864737516024 ACRYLIC FINISH
07-FEB-2008 CSTIC LBLG
Nails For You
Monterrey , MX NOL-DO 112-1241310-1/1/7
95U--20 UV Lamp
07-FEB-2008 NON STD
ERS HUASTECA EXPORT
VERACRUZ MX-VER, MX 91950 SWI-DO BYX-0007013-0/1/1
24AFC14 1224 BX GREENBEANS
08-FEB-2008 PESTICIDE
Pesquera Sejomar, S.A. De C.V.
Mazatlan, Sinaloa , MX 82050 SWI-DO N55-0134879-5/1/1
16AYC42 FRESH SWORDFISH IN BULK
08-FEB-2008 POISONOUS
Pesquera Miriam, S.A. de C.V.
MAZATLAN MX-SIN, MX 00000 SWI-DO N55-0134880-3/1/1
16AYC42 FRESH SWORDFISH
08-FEB-2008 POISONOUS
Fabrica De Chocolates La Popular
Monterrey Nl FN, MX SWI-DO DC1-0067425-8/1/1
34BFT12 SWEET CHOCOLATE IN RETAIL PKGS. (PREMIUM 40/ 4.5 OZ.)
08-FEB-2008 CONTAINER
Abbott Laboratories de Mexico, S.A. de C.V.
Mexico, D.F. D.F., MX 03100 CIN-DO 110-1465291-7/1/2
56ICL10 ERITROMICINA SUSPENSION, NO RX, NO ID, PER USE
11-FEB-2008 UNAPPROVED
Bayer De Mexico Sa De Cv
Mexico Df FN, MX CIN-DO 110-1465291-7/1/3
62GCA50 NAPROXEN SODIUM, NO ID, PER USE
11-FEB-2008 UNAPPROVED
Schering Plough Sa De Cv
Xochimilco, Mexico , MX 106090 CIN-DO 110-1465291-7/1/4
60LDA01 PARACETAMOL/FENILEFRINA/CLORFENAMINA/CAFEINA, PER USE
11-FEB-2008 UNAPPROVED
Glaxosmith Kline
San Lorenzo Huipulcosan Lorenzo Huipulco , M CIN-DO 110-1465291-7/1/5
56CDA27 CEFALEXINA AND AMBROXOL, NO ID, PER USE
11-FEB-2008 UNAPPROVED
Sabritas S. De R.L De C.V.
Mexico D.f., , MX 023000 SWI-DO BYX-0006555-1/1/1A
07BGT02 CHURRUMAIS CORN CHIPS W/ LIME
11-FEB-2008 UNSAFE COL
COLOR LBLG
Sabritas S. De R.L De C.V.
Mexico D.f., , MX 023000 SWI-DO BYX-0006555-1/1/1B
07BGT02 CHURRUMAIS CORN CHIPS W/ LIME
11-FEB-2008 UNSAFE COL
COLOR LBLG
Sabritas S. De R.L De C.V.
Mexico D.f., , MX 023000 SWI-DO BYX-0006555-1/2/1A
07BGT02 SABRITONES WHEAT CHIPS
11-FEB-2008 UNSAFE COL
COLOR LBLG
Sabritas S. De R.L De C.V.
Mexico D.f., , MX 023000 SWI-DO BYX-0006555-1/2/1B
07BGT02 SABRITONES WHEAT CHIPS
11-FEB-2008 UNSAFE COL
COLOR LBLG
Distribuidora De Productos Deshidr-Atados, S.A. De C.V.
San Nicolas De Los Garz , MX 66480 SWI-DO HP7-0094227-6/3/1
24HFH08 DRIED ANCHO PEPPERS
11-FEB-2008 FILTHY
Distribuidora De Productos Deshidr-Atados, S.A. De C.V.
San Nicolas De Los Garz , MX 66480 SWI-DO HP7-0094227-6/3/2
24HFH08 DRIED GUAJILLO PEPPERS
11-FEB-2008 FILTHY
Distribuidora De Productos Deshidr-Atados, S.A. De C.V.
San Nicolas De Los Garz , MX 66480 SWI-DO HP7-0094227-6/3/3
24HFH08 DRIED ARBOL PEPPERS
11-FEB-2008 FILTHY
ALFONSO RUY SANCHEZ
CABORCA MX-SON, MX 83600 SWI-DO 012-0323158-2/1/1
24FFC08 HABANERO PEPPERS
11-FEB-2008 PESTICIDE
Fernando Ruy Sanchez Ramos
Caborca , MX SWI-DO 012-0323192-1/1/1
24FFC08 HABANERO PEPPERS
11-FEB-2008 PESTICIDE
ALFONSO RUY SANCHEZ
CABORCA MX-SON, MX 83600 SWI-DO 012-0323235-8/1/1
24FFC08 HABANERO PEPPERS
11-FEB-2008 PESTICIDE
ALFONSO RUY SANCHEZ
CABORCA MX-SON, MX 83600 SWI-DO 012-0323313-3/1/1
24FFC08 HABANERO PEPPERS
11-FEB-2008 PESTICIDE
Acidos Organicos S.A. De C.V.
Tlalnepantla, Edo. Mexico , MX 54170 SWI-DO KR3-0053141-4/2/1
21UHT14 Tamarind Jam
11-FEB-2008 FILTHY
Distribuidora Agrobaja San Vicente S.P.R.De R.L.
Ensenada B.C. , MX 22785 SWI-DO BRQ-0025552-2/1/1
24FHI08 Ground Red Peppers in Brine Paste (Ingred. = Red chile Pepp
11-FEB-2008 PESTICIDES
Mail Pack S. De R.L. De C.V.
Guadalajaraguadalajara , MX 44150 CIN-DO 110-1578842-1/1/1
60LCA83 CELEBREX 100 MG, NO RX, NO ID
12-FEB-2008 UNAPPROVED
Mail Pack S. De R.L. De C.V.
Guadalajaraguadalajara , MX 44150 CIN-DO 110-1578842-1/1/2
64LCK03 ERISPAN, NO RX, NO ID
12-FEB-2008 DRUG GMPS
UNAPPROVED
Mail Pack S. De R.L. De C.V.
Guadalajaraguadalajara , MX 44150 CIN-DO 110-1578842-1/1/3
66VCA99 TRIBEDOCE, NO RX, NO ID,
12-FEB-2008 UNAPPROVED
Mail Pack S. De R.L. De C.V.
Guadalajaraguadalajara , MX 44150 CIN-DO 110-1578842-1/1/4
64LDA19 DEXIMET, NO RX, NO ID,
12-FEB-2008 UNAPPROVED
Operadora Picazzo S.A. De C.V.
San Pedro Garza Garcia, , MX 66220 SWI-DO DM0-0909397-0/2/1B
33YGT99 MANGO GUMMIES ARTIFICIALLY FLAVORED CANDY 12 X 17.6 OZ
12-FEB-2008 UNSAFE COL
LIST INGRE
FALSE
Galletas Juanita S.A De C.V
San Pedro Atzompa Tecam , MX 55771 SWI-DO NB8-0040478-3/1/1
03MFB99 ASSORTED COOKIES
12-FEB-2008 UNSAFE COL
Convertors De Mexico
Juarez , MX 32500 SWI-DO BJV-0208687-5/2/2
79L--RO STERILE OR SCISSORS
14-FEB-2008 STERILITY
Empaque Don Jorge
El Rosario Mx-Sin, MX 82800 SWI-DO APF-9006568-9/1/2
24FFC08 PASILLA PEPPERS
14-FEB-2008 PESTICIDE
Empaque Don Jorge
El Rosario Mx-Sin, MX 82800 SWI-DO APF-9006569-7/1/2
24FFC08 PASILLA PEPPERS
14-FEB-2008 PESTICIDE
Empaque Don Jorge
El Rosario Mx-Sin, MX 82800 SWI-DO APF-9006626-5/1/1
24FFC08 PASILLA PEPPERS
14-FEB-2008 PESTICIDE
Empaque Don Jorge
El Rosario Mx-Sin, MX 82800 SWI-DO APF-9006808-9/1/3
24FFC08 PASILLA PEPPERS
14-FEB-2008 PESTICIDE
Empaque Don Jorge
El Rosario Mx-Sin, MX 82800 SWI-DO APF-9006959-0/1/2
24FFC08 PASILLA PEPPERS
14-FEB-2008 PESTICIDE
Empaque Don Jorge
El Rosario Mx-Sin, MX 82800 SWI-DO APF-9007018-4/1/1
24FFC08 PASILLA PEPPERS
14-FEB-2008 PESTICIDE
Empaque Don Jorge
El Rosario Mx-Sin, MX 82800 SWI-DO APF-9007100-0/1/3
24FFC08 PASILLA PEPPERS
14-FEB-2008 PESTICIDE
Chiles Secos Y Semillas Ramos Hermanos
Juarez Chihuahua, MX SWI-DO AF4-0358849-0/4/1
23BGH05 DEHYDRATED SHREDDED COCONUT
14-FEB-2008 EXCESS SUL
Ramos Hnos. Internacional, S.P.R. De R.L. De C.V.
Camargo,Chihuahua;Mexico , MX SWI-DO AF4-0319658-3/1/1
24HFH08 DRIED GUAJILLO PEPPERS
15-FEB-2008 FILTHY
SALMONELLA
Novartis Farmaceutica S.A. De C.V.
San Diego , MX 04120 CIN-DO 110-1566858-1/1/1
62GQC18 DICLOFENACO SODICO, VETERINARIAN MEDICINE,
15-FEB-2008 NEW VET DR
Mail Pack S. De R.L. De C.V.
Guadalajaraguadalajara , MX 44150 CIN-DO 110-1530540-8/1/1
64MCK99 PREGNYL INJECTIBLE SOLUTION, NO RX, NO ID
15-FEB-2008 DRUG GMPS
UNAPPROVED
Mail Pack S. De R.L. De C.V.
Guadalajaraguadalajara , MX 44150 CIN-DO 110-1530540-8/1/2
56BCA03 AMOXICILLINA, NO RX, NO ID
15-FEB-2008 UNAPPROVED
Mail Pack S. De R.L. De C.V.
Guadalajaraguadalajara , MX 44150 CIN-DO 110-1530524-2/1/1
64MCK99 PREGNYL FOR INJECTION, NO RX, US CIT, PER USE
15-FEB-2008 DRUG GMPS
UNAPPROVED
Queseria Dos Lagunas S. de P.R.
Cd. Juarez MX-CHH, MX 32360 SWI-DO 328-0921069-6/1/1
12CGT13 ROUND SHAPED MENONITA CHEESE C.HOLANDES
15-FEB-2008 BACTERIA
LABELING
Queseria Dos Lagunas S. de P.R.
Cd. Juarez MX-CHH, MX 32360 SWI-DO 328-0920944-1/1/1
12CGT13 Round Shaped Menonita Cheese (Wheels)
15-FEB-2008 BACTERIA
Queseria Dos Lagunas S. de P.R.
Cd. Juarez MX-CHH, MX 32360 SWI-DO 328-0920832-8/1/1
12CGT13 ROUND SHAPED MENONITA CHEESE C.HOLANDES
15-FEB-2008 BACTERIA
Delicias De Jalisco
Guadalajara, Jalisco , MX SWI-DO H87-0157636-0/3/6
33HGT05 Coco Bandera Coconut Candy
15-FEB-2008 UNSAFE COL
procesadora de dulces tipicos, s.a. de c.v.
guadalajara MX-JAL, MX 44250 SWI-DO M42-3135103-0/1/1
33HGT05 ROLLOS DE COCO DELICIAS- COCONUT ROLLS
15-FEB-2008 SULFITELBL
NUTRIT LBL
Cosbel Sa
Mexico , MX SWI-DO D01-0817159-2/1/1
53FY-02 ROJOS VOLCANICOS 100% COLOR HAIR TINT KIT
15-FEB-2008 COLOR LBLG
Boehringer Ingelheim Promeco
Barrio Xaltocan , MX CIN-DO 110-1683457-0/1/1
60LCS21 METAMIZOL SODICO, FOR CIT PER USE
21-FEB-2008 UNAPPROVED
Lakesida de Mexico, S.A. de C.V.
Toluca , MX 50030 CIN-DO 110-1683457-0/1/2
56BCK10 BENCILPENICILINA PROCAINICA, FOR CIT PER USE
21-FEB-2008 DRUG GMPS
UNAPPROVED
A & C Service De Mexico Sa De Cv
Mexicomexico , MX 06760 CIN-DO 110-1683457-0/1/5
80K--ZH SYRINGES, FOR CIT PER USE
21-FEB-2008 NOT LISTED
REGISTERED
NO 510(K)
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BIM-1105243-3/1/1
33SGT06 Vero mango Lollipop with chili
21-FEB-2008 FILTHY
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BIM-1105243-3/2/1
33SGT06 Rellerindos, tamarind flavor candies
21-FEB-2008 FILTHY
HELI GUADALUPE FLORES PULIDO
VICTORIA MX-TAM, MX 87120 SWI-DO M92-5015942-0/1/1
24FGC08 FRESH JALAPENO PEPPER
22-FEB-2008 PESTICIDE
Laboratorios Silanes
Juarez , MX 03100 NOL-DO 112-0045739-1/1/1
57AF-09 863356286190-ANTIVENIN
25-FEB-2008 NO LICENSE
Alimentos Avanzados
Zapopan MX-JAL, MX 45030 SWI-DO ARS-7000577-0/8/1
05AGT06 Toasted Bran
26-FEB-2008 LIST INGRE
LACKS FIRM
USUAL NAME
NUTRIT LBL
Mega Frescos Del Bajio Sa De Cv
Salamanca Guanajuato Mx , MX SWI-DO 918-4555526-6/1/2
24FFC07 YELLOW BELL PEPPER
26-FEB-2008 PESTICIDE
Mega Frescos Del Bajio Sa De Cv
Salamanca Guanajuato Mx , MX SWI-DO 918-4555451-7/1/2
24FFC07 YELLOW BELL PEPPER
26-FEB-2008 PESTICIDE
Mega Frescos Del Bajio Sa De Cv
Salamanca Guanajuato Mx , MX SWI-DO 918-4555451-7/1/4
24FFC07 MIXED PEPPERS
26-FEB-2008 PESTICIDE
Mega Frescos Del Bajio Sa De Cv
Salamanca Guanajuato Mx , MX SWI-DO 918-4555451-7/1/5
24FFC07 BABY MIXED PEPPERS
26-FEB-2008 PESTICIDE
Panasonic De Mexico S.A. De C.V.
Ixtapaluca , MX FLA-DO 406-0412076-2/1/1
94R--BB COLOR TV SET - FOR EXPORT ONLY
28-FEB-2008 NON STD
Pakmail Lindavista
Mexicomexico , MX 07300 CIN-DO UPS-0064160-3/1/1
60LDA82 PIRIFUR, NO RX, NO ID, PER USE
28-FEB-2008 UNAPPROVED
Pakmail Lindavista
Mexicomexico , MX 07300 CIN-DO UPS-0064160-3/1/2
62GCA94 SUPRADOL, NO RX, NO ID,PER USE
28-FEB-2008 UNAPPROVED
Pakmail Lindavista
Mexicomexico , MX 07300 CIN-DO UPS-0064160-3/1/3
61HDA03 BACTRIM F, NO RX, NO ID, PER USE
28-FEB-2008 UNAPPROVED
Comercializadora Agricola Treto, Spr De Ri.
Villa De Ahome Sinaloa Rfc# C , M SWI-DO 174-0166105-7/1/1
24AYB60 CORN,BULK ( VEGE);NOT ELSEWHERE CLASSIFIED (NEC);RAW, FRESH,
28-FEB-2008 INSANITARY
ALIMENTOS TRES G SA DE CV
SAN NICOLAS MX-NLE, MX 66484 SWI-DO DV1-0092870-9/12/1
27YGT06 Habanero Mexican Salsa
29-FEB-2008 NO PROCESS
Distribuidora La Casa Grande
San Pedro,Santiago,N.L.Mexico. , MX SWI-DO 392-0112541-4/59/1
36CCT01 Honey with comb
29-FEB-2008 FALSE
LACKS FIRM
Apicola De Allende S.A. De C.V.
Allende,N.L. Mexico , MX 67350 SWI-DO 392-0112541-4/60/1
36CCT01 Honey with comb
29-FEB-2008 FALSE
LACKS FIRM
Apicola De Allende S.A. De C.V.
Allende,N.L. Mexico , MX 67350 SWI-DO 392-0112541-4/61/1
36CCT01 Honey with comb.
29-FEB-2008 FALSE
LACKS FIRM
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO ANG-0013937-9/3/1
33UGT01 VERO BOLIGOMA 20
29-FEB-2008 FILTHY