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
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007183-5/1/1A
29BGT99 Pepsi soda
03-DEC-2007 NO ENGLISH
NUTRIT LBL
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007183-5/1/1B
29BGT99 Mirinda orange soda
03-DEC-2007 UNSAFE COL
COLOR LBLG
NO ENGLISH
NUTRIT LBL
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007183-5/1/1C
29BGT99 Okey pineapple soda
03-DEC-2007 COLOR LBLG
NO ENGLISH
NUTRIT LBL
YELLOW #5
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007183-5/1/1D
29BGT99 Okey orange soda
03-DEC-2007 UNSAFE COL
COLOR LBLG
NO ENGLISH
NUTRIT LBL
YELLOW #5
La Chicanita
Puebla , MX NYK-DO BNI-0007183-5/1/1E
24FCY05 Flor de calabaza large size (Pumpkin flower)
03-DEC-2007 NEEDS FCE
NO PROCESS
La Chicanita
Puebla , MX NYK-DO BNI-0007183-5/1/1F
24FCY05 Flor de calabaza small size (Pumpkin flower)
03-DEC-2007 NEEDS FCE
NO PROCESS
Salsa Tamazula, S. A.
Guadalajara JAL, MX 44940 NYK-DO BNI-0007183-5/1/1H
37JCY99 Valentina 1 Liter hot sauce
03-DEC-2007 NO ENGLISH
Salsa Tamazula, S. A.
Guadalajara JAL, MX 44940 NYK-DO BNI-0007183-5/1/1I
37JCY99 Valentina 370 mL hot sauce
03-DEC-2007 NO ENGLISH
Cerveceria Modelo, S.A. de C.V.
Mexico MX-DIF, MX 11320 NYK-DO BNI-0007183-5/1/1J
32ACY04 Corona Beer (Victoria)
03-DEC-2007 NO ENGLISH
La Japonesa
Chihuahua MX-CHH, MX 31000 SWI-DO 725-0902024-3/1/2
31KYH99 HERBAL TEA TIZANA UVA
03-DEC-2007 NO ENGLISH
UNAPPROVED
La Japonesa
Chihuahua MX-CHH, MX 31000 SWI-DO 725-0902024-3/1/3
31KYH99 HERBAL TEA ULCEMA
03-DEC-2007 NO ENGLISH
UNAPPROVED
Glezte S.P.R De R.I
Mexico , MX FLA-DO FY5-0013560-0/1/1
28AGC04 BASIL
04-DEC-2007 PESTICIDE
Procesadora De Alimentos Cale, S.A. de C.V.
Tlaquepaque , MX 45618 SWI-DO M42-3134853-1/2/1
33SGT06 PALETA PIKA SLICE/ LOLLIPOPS
04-DEC-2007 FILTHY
CURVAS INTERNACIONALES FARMS
LLERA MX-TAM, MX 87200 SWI-DO BYX-0005643-6/12/1
24FGC08 20 sacks Serrano Peppers
04-DEC-2007 PESTICIDE
Agroindustrias Aztecs S.A. De C.V.
San Pedro Garza Garcia Nuevo Leon, MX SWI-DO DC1-0070247-1/1/1
24KEI51 Red Hot Sauce
04-DEC-2007 PESTICIDES
Frumexam
Ciudad Juarez , MX 77333 SWI-DO U32-0011978-2/7/1
24FFB08 FRESH JALAPENO PEPPERS IN BOXES
04-DEC-2007 PESTICIDE
Alimentos Naturales Sabroza Sa de CV
Guadalupe Nuevo Leon, MX 1234 SWI-DO WC1-8176478-6/2/1
24KCY08 CHIPOTLE SALSA
04-DEC-2007 PESTICIDES
Mega Alimentos, Sa De Cv
Santa Catarina NL, MX 66350 SWI-DO BPI-0010343-6/1/1
24KHT08 LA BOTANERA HOT SAUCE
04-DEC-2007 PESTICIDES
Mega Alimentos, Sa De Cv
Santa Catarina NL, MX 66350 SWI-DO BPI-0010360-0/1/1
24KHT08 LA BOTANERA HOT SAUCE
04-DEC-2007 PESTICIDES
Marquez Brothers International, Sa De Cv
Romita, Gto. Mexico , MX 36200 SWI-DO WS7-0025924-5/4/1
30NGT03 TAMARINDO DRINK MIX
04-DEC-2007 FILTHY
Empresas Tajin Sa De Cv
Zapopan Jalisco , MX 45019 SWI-DO BVK-0021986-0/19/1
28BGT08 CHILI POWDER
04-DEC-2007 POISONOUS
Comercializadora Eloro Sa
Ecatepec , MX 55340 SWI-DO 705-0461782-3/1/1
20DFE99 JUMEX BLENDS Berry Sensation
04-DEC-2007 NUTRIT LBL
HEALTH C
Comercializadora Eloro Sa
Ecatepec , MX 55340 SWI-DO 705-0461782-3/2/1
20KFE99 JUMEX BLENDS Citrus Brust
04-DEC-2007 FALSE
HEALTH C
Scorpion Mezcal S.A. de C.V.
Oaxaca MX-OAX, MX 71238 SWI-DO 101-3068163-7/2/1B
27YGT99 DEHYDRATED GRASSHOPPERS COOKED IN PLASTIC BAG
04-DEC-2007 NO ENGLISH
EDUARDO ESCAMILA
PHOENIX, AZ 85033-3333 LOS-DO XXX-0152728-3/1/1
03AYY01 BAKED BREAD / ROLLS
05-DEC-2007 LIST INGRE
FILTHY
BACTERIA
LACKS FIRM
LACKS N/C
NO ENGLISH
OFF ODOR
NUTRIT LBL
EDUARDO ESCAMILA
PHOENIX, AZ 85033-3333 LOS-DO XXX-0152728-3/1/2
23MMY99 NUTS & SEEDS
05-DEC-2007 FILTHY
LACKS FIRM
LACKS N/C
NO ENGLISH
OFF ODOR
Juan Ramon Ganem Vargas
Tuxpanveracruz, Mexico 92773 , MX SWI-DO MY8-1002722-6/2/1
16AFC99 1 Large Tote of Refrigerated Oilfish
05-DEC-2007 HISTAMINE
Jafet Sanchez
Puebla , MX NYK-DO H67-1301169-9/3/1A
07YFT99 Totis snack with salt and lemon
05-DEC-2007 UNSAFE COL
Jansen Cilag S.A.De C.V.
Huejozingo, Puebla , MX NOL-DO 112-0153722-5/1/1
61WAH46 862506194395/SPORASEC
05-DEC-2007 UNAPPROVED
AGRICOLA MAUI S DE RL DE CV
CABORCA MX-SON, MX 83600 SWI-DO K76-0524394-1/2/1
24FFC20 CUCUMBERS 1 1/9 BUSHEL
06-DEC-2007 PESTICIDE
Unomedical S.A. de C.V.
Reynosa , MX 1234 SWI-DO 027-3077095-1/20/1
73B--YD HEAT & MOISTURE EXCHANGER, BACTERIAL/VIRAL FILTER
07-DEC-2007 DEVICEGMPS
Productos Vigar Sa De Cv
San Nicolas De Los Garz , MX SWI-DO DV1-0090756-2/3/1
07BGT02 Corn Chips w/ Salt and Limon
07-DEC-2007 NO ENGLISH
TRANSFAT
SALMONELLA
AZUCARES DULCES PRODUCE
MARTINEZ DE LA TORRE MX-VER, MX 93600 SWI-DO DV1-0090791-9/1/1
24HFH08 1686 BXS DRY PULLA PEPPER
07-DEC-2007 FILTHY
Jafet Sanchez
Puebla , MX NYK-DO H67-1299314-5/3/1
24FET05 Pumpkin flower
08-DEC-2007 NEEDS FCE
NO PROCESS
quesos sabrosos mexicanos s.a. de c.v.
villahermosa MX-TAB, MX 86100 SWI-DO M29-2020233-2/1/1
12CGT13 Queso cincho Guarrero duro anejado
10-DEC-2007 MFR INSAN
SALMONELLA
Pakamil Pachuca
Pachucapachuca , MX 42060 CIN-DO 110-0922497-9/1/1
66VCK99 UNDECLARED MEDS/NO LABELING/RE-PACK BY PSC/ NO RX/NO ID
10-DEC-2007 DRUG GMPS
UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/1
66VCA99 AMBROXOL BIONOXOL, NO RX, NO FOR ID (NO PHONE # FOR IMPORTER
10-DEC-2007 UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/2
66VCA99 MICONAZOL NACOMIC CREME, NO RX, NO FOR ID
10-DEC-2007 UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/3
66VCA99 METRONIDAZOL, NO RX, NO FOR ID
10-DEC-2007 UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/4
66VCA99 NAPROXENO, NO RX, NO FOR ID
10-DEC-2007 UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/5
66VCA99 ACIDO ACETILSALICILICO, NO RX, NO FOR ID
10-DEC-2007 UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/6
66VCA99 RANITIDINA RIDAREM, NO RX, NO FOR ID
10-DEC-2007 UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/7
66VCA99 CLORFENAMINA COMPUESTA BIOFLUSIN, NO RX, NO FOR ID
10-DEC-2007 UNAPPROVED
Mercado Rubio Adolfo Fermin
Atlacomulco Estado De Matlacomulco Estad , M CIN-DO 110-0712625-9/1/8
66VCA99 MISC PILLS, TAPED & ROLLED UP, NO RX, NO FOR ID (NO PHONE# F
10-DEC-2007 UNAPPROVED
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1A
29BGT99 Miranda Orange Soda
12-DEC-2007 UNSAFE COL
NO ENGLISH
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1B
29BGT99 Pepsi Cola Soda
12-DEC-2007 NO ENGLISH
NUTRIT LBL
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1C
29BGT99 Coke Cola Soda
12-DEC-2007 NO ENGLISH
NUTRIT LBL
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1D
29BGT99 Squirt Soda
12-DEC-2007 NO ENGLISH
NUTRIT LBL
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1E
29BGT99 Corona Beer
12-DEC-2007 NO ENGLISH
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1F
29BGT99 Valentina Sauce
12-DEC-2007 NO ENGLISH
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1G
29BGT99 Valentina Sauce
12-DEC-2007 NO ENGLISH
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007186-8/1/1H
29BGT99 Flor De Calabraza
12-DEC-2007 NEEDS FCE
NO PROCESS
Chupa Chups Industrial Mexicana S.A. de C.V.
Toluca MX-NOTA, MX 50200 FLA-DO 408-1150300-9/1/1
33SYY06 SUGAR CANDIES
12-DEC-2007 UNSAFE COL
Smith Medical
Apodacaapodaca , MX 66600 NOL-DO 112-0536458-4/1/1
80K--ZH 935769973387 SYRINGES
14-DEC-2007 NOT LISTED
NO 510(K)
ALFONSO RUY SANCHEZ
CABORCA MX-SON, MX 83600 SWI-DO 012-0322419-9/2/1
24FFC08 HABANERO PEPPERS
17-DEC-2007 PESTICIDE
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007321-1/1/1A
29BGT99 Okey apricot soda (durazno)
19-DEC-2007 UNSAFE COL
COLOR LBLG
NO ENGLISH
NUTRIT LBL
YELLOW #5
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007321-1/1/1B
29BGT99 Mirinda orange soda
19-DEC-2007 NO ENGLISH
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007321-1/3/1
07BGT06 Churrumais corn chips
19-DEC-2007 NO ENGLISH
Exportaciones San Miguel Axutla. S.A de C.V.
Puebla. MX-PUE, MX 72497 NYK-DO BNI-0007321-1/1/1C
29BGT99 Squirt grapefruit soda
19-DEC-2007 NO ENGLISH
NUTRIT LBL
Cadbury Aguas Minerales Sa De Cv
Ciudad , MX NYK-DO BNI-0007321-1/1/1D
29WCY99 Penafiel mineral water
19-DEC-2007 NO ENGLISH
Cerveceria Modelo, S.A. de C.V.
Mexico MX-DIF, MX 11320 NYK-DO BNI-0007321-1/1/1E
32ACY04 Corona beer (Victoria)
19-DEC-2007 NO ENGLISH
Alimentos Naturales Sabroza Sa de CV
Guadalupe Nuevo Leon, MX 1234 SWI-DO WC1-8183030-6/1/1
24KCT08 LA SABROZA CHIPOTLE HOT SAUCE
19-DEC-2007 PESTICIDES
Alimentos Naturales Sabroza Sa de CV
Guadalupe Nuevo Leon, MX 1234 SWI-DO WC1-8183030-6/1/2
24KCT08 LA PREFERIDA CHIPOTLE HOT SAUCE
19-DEC-2007 PESTICIDES
Alimentos Naturales Sabroza Sa de CV
Guadalupe Nuevo Leon, MX 1234 SWI-DO WC1-8183030-6/2/1
24KCY08 LA SABROZA ARBOL PEPPER HOT SAUCE
19-DEC-2007 PESTICIDES
Alimentos Naturales Sabroza Sa de CV
Guadalupe Nuevo Leon, MX 1234 SWI-DO WC1-8183030-6/2/3
24KCY08 GOYA SALSITA HABANERO HOT SAUCE
19-DEC-2007 PESTICIDES
Alimentos Naturales Sabroza Sa de CV
Guadalupe Nuevo Leon, MX 1234 SWI-DO WC1-8183893-7/2/1
24KCT08 LA PREFERIDA CHIPOTLE HOT SAUCE
19-DEC-2007 PESTICIDES
Productos Del Campo
Aguascalientes , MX SWI-DO BJG-0007672-8/1/1
24HFH08 DRY ANCHO PEPPERS
19-DEC-2007 FILTHY
La Chicanita
Puebla , MX SWI-DO DV1-0091223-2/4/1
24FCI06 Pumpkin Flower in Syrup
19-DEC-2007 NEEDS FCE
NO PROCESS
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BYX-0005727-7/5/1
33SGT06 VERO BARRIL DEL CHAVO LOLLIPOP W/ CHILE POWDER
19-DEC-2007 NO ENGLISH
Fabrica De Chocolates La Popular
Monterrey Nl FN, MX SWI-DO DC1-0067425-8/1/2
34BFT12 SWEET CHOCOLATE IN RETAIL PKGS. (POLAR 40 / 4.5 OZ.)
19-DEC-2007 POISONOUS
Fabrica De Chocolates La Popular
Monterrey Nl FN, MX SWI-DO DC1-0067551-1/1/1
34BFT12 600 Cases Sweet Chocolate in Retail Pkgs.
19-DEC-2007 POISONOUS
Fabrica De Chocolates La Popular
Monterrey Nl FN, MX SWI-DO DC1-0067552-9/1/1
34BFT12 100 Cases Sweet Chocolate in Retail Pkgs.
19-DEC-2007 POISONOUS
Fabrica De Chocolates La Popular
Monterrey Nl FN, MX SWI-DO DC1-0067603-0/1/1
34BFT12 400 Cases La Popular Sweet Chocolate
19-DEC-2007 POISONOUS
Productos Sierra Vieja
Nuevo Laredo,Tamps. , MX 88280 SWI-DO BUV-0008547-7/1/1
24HFB08 DRY GUAJILLO PEPPERS
19-DEC-2007 FILTHY
Fabrica De Chocolates La Popular
Monterrey Nl FN, MX SWI-DO DC1-0067596-6/1/1
34BFT12 400 Cases Sweet Chocolate in retail pkgs.
19-DEC-2007 POISONOUS
Productos Vigar Sa De Cv
San Nicolas De Los Garz , MX SWI-DO DV1-0090488-2/1/1B
07BGT02 (Tricachos) chile, salt & lime flavored fried corn chips
19-DEC-2007 SALMONELLA
Semillas Buen Temporal
Fresnillo , MX SWI-DO DV1-0090841-2/1/1
24HFH08 1200 BXS DRY ANCHO PEPPER
20-DEC-2007 FILTHY
Natural Alimenticia Sa De Cv
Soledad De Graciano Sans.L.P. , MX SWI-DO DV1-0091352-9/1/1
24HFH08 DRY GUAJILLO PEPPER
20-DEC-2007 FILTHY
Baker & Mckenzie
Mexico , MX NOL-DO 112-0597353-3/1/1
80M--SH 863822155881/RESPIRATOR MACHINE
20-DEC-2007 NOT LISTED
NO 510(K)
Roche Cintex
Colonia Lomade , MX NOL-DO 112-0618700-0/1/1
66MDB75 864084358764 LEXOTAN 6G
21-DEC-2007 UNAPPROVED
comercializadora interveggie s.a. de c.v.
culiacan MX-SIN, MX 80011 SWI-DO 174-0162186-1/1/1
24AJC14 GREEN BEANS
27-DEC-2007 PESTICIDE
Guadalupe De Guaymas, S.P.R. De R.L.
Guaymas Sonora, MX 85440 SWI-DO BDJ-0057889-7/2/3
22AFC01 CANTALOPES 15'S
27-DEC-2007 SALMONELLA
Guillermo Rojas Sotre
Vizcaino, B.C. , MX SWI-DO KD5-1168346-8/6/3
24TJB99 CACTUS LEAVES
31-DEC-2007 PESTICIDE
Mario Villa Hernandez
Michoacan MX-MIC, MX 60626 SWI-DO KD5-1168223-9/9/1
21SFC06 FRESH PAPAYA
31-DEC-2007 PESTICIDE
La Bodeguita (Jorge Martinez Pasillas)
Aguascaliente , MX SWI-DO BYX-0005590-9/1/1
24HFH08 1648 BX DRY ANCHO PEPPER
31-DEC-2007 PESTICIDES
CURVAS INTERNACIONALES FARMS
LLERA MX-TAM, MX 87200 SWI-DO DR4-0112612-0/1/1
24HGH08 DRY PEPPER GUAJILLO
31-DEC-2007 FILTHY
Productos Vigar Sa De Cv
San Nicolas De Los Garz , MX SWI-DO DV1-0090488-2/1/1A
07BGT02 (picachitos) cheese & jalapeno pepper fried corn chips shape
31-DEC-2007 UNSAFE COL
COLOR LBLG
SALMONELLA
AZUCARES DULCES PRODUCE
MARTINEZ DE LA TORRE MX-VER, MX 93600 SWI-DO DV1-0091448-5/1/1
21SFC06 1100 BXS FRESH PAPAYA
31-DEC-2007 PESTICIDE