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
Alimentos Naturales Sabroza Sa de CV
Guadalupe Nuevo Leon, MX 1234 SWI-DO WC1-8228465-1/1/1
24KCY08 RED HOME STYLE SALSA WITH CILANTRO (LA SABROZITA)
01-JUL-2008 NO PROCESS
Productos Karla S A De C V
Zacatecas Jalisco, MX SWI-DO WC1-8236912-2/1/8
21TGT14 TAMARIND & GUAVA ARTIFICIAL FLAVOR SOFT CANDY VASITO
01-JUL-2008 PB-FOOD
EMPACADORA HUASTECA 2007
TAMPICO MX-TAM, MX 89001 SWI-DO M92-5016849-6/2/1
24HFH08 DRY PIKIN PEPPER
01-JUL-2008 FILTHY
Edelia Rodriguez
Leon , MX 37360 NOL-DO 112-1316309-3/1/1A
53LC-01 864736761644 crema conchanacar
02-JUL-2008 CSTIC LBLG
COSMETLBLG
El Azteca S.A. de C.V.
Guadalajara Jalisco, MX SWI-DO ANG-0015635-7/4/1
33HGT05 105 Cases El Azteca Coconut Candy Rolls
07-JUL-2008 LACKS N/C
Pak Logistic
Naucalpan Edo , MX CIN-DO UPS-1385971-3/1/1
66VCA99 LINCOCIN/NO RX/NO ID/PER USE
08-JUL-2008 UNAPPROVED
Pak Logistic
Naucalpan Edo , MX CIN-DO UPS-1385971-3/1/2
66VCA99 EUCALIPITINE/NO RX/NO ID/PER USE(20 VIALS)
08-JUL-2008 UNAPPROVED
Pak Logistic
Naucalpan Edo , MX CIN-DO UPS-1385971-3/1/3
66VCA99 ANALEGEN FORTE/NO RX/NO ID/PER USE
08-JUL-2008 UNAPPROVED
Conservas Y Congelados De Mexico Sa
Mexico Df , MX 10200 SWI-DO BCV-0009177-4/2/1
25YDF99 PUMPKIN FLOWER IN BRINE
08-JUL-2008 FILTHY
RANCHO ROSARITO
ROSARITO MX-BCN, MX 22710 SWI-DO 711-1227692-9/1/1
24TFB46 FRESH CILANTRO
08-JUL-2008 SALMONELLA
Alejandro Lara Correa
Calera V.R. , MX CHI-DO 120-0217421-2/1/1
24HFH08 PERISHABLE DRY PEPPERS
09-JUL-2008 FILTHY
Malabar Productos Naturales, Sa Ce Cv
Guadalupe , MX SWI-DO CAV-0001263-3/1/3
31KFH99 CHAMOMILE TEA
10-JUL-2008 SALMONELLA
Herbal Solutions Health, S.A. de C.V.
Irapuato MX-GUA, MX 36500 SWI-DO 228-5074694-6/14/1
66VBJ99 FACIAL GEL CLEAR & BALANCE
10-JUL-2008 NOT LISTED
DIRECTIONS
Herbal Solutions Health, S.A. de C.V.
Irapuato MX-GUA, MX 36500 SWI-DO 228-5074694-6/7/1
66VBH99 ACNE SOLUTIONS CAPSULES
10-JUL-2008 DIRECTIONS
Deshidratadora Santa Anita
Asientos MX-AGU, MX 20780 SWI-DO H87-0162441-8/1/1
24FFH08 CASCABEL DRIED PEPPERS
10-JUL-2008 SALMONELLA
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BRQ-0031424-6/4/2
33EGT06 PICA GOMA FRESA FLAVOR SOFT CANDY
10-JUL-2008 FILTHY
Central Alberta Compounding Centre
Red Deer AB, CA CIN-DO UPS-1363504-8/1/1
64GIK08 ESTRADIOL BENZOATE, INJECTIBLE SOLUTION, FDA NEEDED TO ABAND
11-JUL-2008 DRUG GMPS
UNAPPROVED
Central Alberta Compounding Centre
Red Deer AB, CA CIN-DO UPS-1363504-8/1/2
64GIK99 ESTRADIOL PROGESTERONE, INJECTIBLE SOLUTION, FDA NEEDED TO A
11-JUL-2008 DRUG GMPS
UNAPPROVED
SERVICIOS DE PERSONAL HL, S.A. DE C.V.
REYNOSA MX-TAM, MX 88500 SWI-DO BYX-0009198-7/8/1
24TJB46 240 BX CORIANDER
11-JUL-2008 SALMONELLA
PRODUCTOS LA COLINA S.A. DE C.V.
Tlaquepaque MX-JAL, MX 45601 SWI-DO BDJ-2001939-3/1/1
24HFH08 DRIED PEPPERS
14-JUL-2008 FILTHY
Reytek S.A.
Yucatan , MX FLA-DO 112-3422696-0/1/1
76N--SL 865297621778 /DENTURES
15-JUL-2008 REGISTERED
Reytek S.A.
Yucatan , MX FLA-DO 112-3422696-0/1/2
76D--ZA 865297621778/DRILL
15-JUL-2008 REGISTERED
Delicias De Jalisco
Guadalajara, Jalisco , MX SWI-DO 392-0115672-4/50/1
33HGT05 CANDIES MEGA BANDERA CASA GRANDE
15-JUL-2008 UNSAFE COL
Tamarindos Selectos De Colima
Colima, Col , MX 30505 SWI-DO 175-1879849-5/1/1
21SYD14 FRESH TAMARIND
15-JUL-2008 FILTHY
Productos Karla S A De C V
Zacatecas Jalisco, MX SWI-DO BRQ-0029166-7/1/13
33SGT06 Sandillon carmel lollipop w/chili, watermelon flavor
15-JUL-2008 FILTHY
ESPECIAS NATURALES DEMEXICO,SA CV
GUADALAJARA MX-JAL, MX 06600 SWI-DO ASC-0012868-8/2/1
50CAB01 ANNATTO SEED PASTE - SMASH
15-JUL-2008 SALMONELLA
Effem Mexico Inc Y Compania S. EN N.C.
Queretaro Mx-Nota, MX 76260 SWI-DO BRQ-0031156-4/2/2
33SGT99 SWINKLES MANGO AND CHAMOY FLAVORED SOFT CANDY
15-JUL-2008 UNSAFE COL
Deshidratadora Santa Anita
Asientos MX-AGU, MX 20780 SWI-DO 175-1880418-6/1/1A
24HGH08 Ground California Pepper
15-JUL-2008 SALMONELLA
Confitados finos del bosque, S.A. de C.V.
Guadalajara MX-JAL, MX 45660 SWI-DO BRQ-0030149-0/1/4
34FET02 Huevines Chocolate Filled Candy
15-JUL-2008 PB-FOOD
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BRQ-0031854-4/1/9
33LGT99 PICAGOMAS FRESA FLAVOR SOFT CANDY
15-JUL-2008 FILTHY
Productos Naturales Garvar Penaf
Puebla , MX 72440 SWI-DO U84-0056709-4/1/1
25YGE99 OTHER VEGETABLE JUICE (CACTUS JUICE).
15-JUL-2008 NEEDS FCE
NO PROCESS
Gerardo Romo Najera
Rincon De Romos , MX SWI-DO 725-0905105-7/1/1
52AIE35 CLAY ARTICLES
15-JUL-2008 POISONOUS
Botanas la mesa
Juarez MX-CHH, MX 32100 SWI-DO 725-0905120-6/3/1
07BGN99 CORN CHIPS SNACKS
15-JUL-2008 SALMONELLA
Janssen Cilag S.A. De C.V.
Mexico , MX FLA-DO 112-3367730-4/3/1
61WCJ18 865811004677 DAKTACORT
16-JUL-2008 UNAPPROVED
TICE Mozzarella Plant S.A. de C.V.
Guadalajara MX-JAL, MX 44470 SWI-DO 918-4565561-1/1/2
12CVO13 1-2.40 KG FRESH MOZARELLA CHEESE 200 GR
16-JUL-2008 INSANITARY
TICE Mozzarella Plant S.A. de C.V.
Guadalajara MX-JAL, MX 44470 SWI-DO 918-4565561-1/1/1
12CVO13 1-3 KG FRESH MOZZARELLA CHEESE 1 KG
16-JUL-2008 INSANITARY
La Imperial, S.A.
Monterrey, Nl Mexico , MX SWI-DO ANG-0015133-3/5/1
33UGE02 LA IMPERIAL CHICLE TOTITO UVA
18-JUL-2008 UNSAFE COL
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BZY-0007300-8/2/1
33LGY02 VERO PICAGOMA MANGO 24X100
18-JUL-2008 FILTHY
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BZY-0007300-8/14/1
33SGY06 VERO PALETA PATADAS SANDIA C/CHILE
18-JUL-2008 FILTHY
Conficorp Sa De Cv
Tepozotian , MX SWI-DO K83-0103669-6/3/1
28BHH08 CHILI POWDER
21-JUL-2008 FILTHY
Productos Karla S A De C V
Zacatecas Jalisco, MX SWI-DO WC1-8242451-3/1/14
33SGT06 PINEAPPLE FLAVORED CARAMEL LOLLIPOP W/ CHILI (JILOTES)
21-JUL-2008 FILTHY
R.M. CAMPO DULCE S.A. DE C.V.
HERMOSILLO MX-SON, MX 83010 SWI-DO APF-9014699-2/1/1
24FFC08 JALAPENO PEPPERS BIN CTN
21-JUL-2008 SALMONELLA
Selecto Productos S.A. de C.V.
Chihuahua , MX 31109 SWI-DO U32-0013175-3/1/2
05AGT04 READY TO EAT WHEAT SWEETENED PUFFED CEREAL - CHOCOLATE
21-JUL-2008 NUTRIT LBL
Selecto Productos S.A. de C.V.
Chihuahua , MX 31109 SWI-DO U32-0013131-6/1/2
05AGT04 Sweetened Puffed Whole Wheat - Chocolate Flavor
21-JUL-2008 NUTRIT LBL
COMERCIALIZADORA JAIME MENDEZ BARRIOS
Reynosa MX-TAM, MX 88500 SWI-DO DR4-0121617-8/4/1
24TFC46 CORIANDER,(CILANTRO),FRESH
22-JUL-2008 SALMONELLA
Bard Reynosa S.A. De C.V.
Reynosa, Tamaulipas Tamaulipas, MX 88000 SWI-DO UPS-0043278-6/1/5
80L--JS POWER PICC SOLO CATHETER 5FR D W/ LIDOCAINE
22-JUL-2008 DE/RX KIT
Bard Reynosa S.A. De C.V.
Reynosa, Tamaulipas Tamaulipas, MX 88000 SWI-DO UPS-0043278-6/1/6
80L--JS 6FR TRIPLE LUMEN POWER PICC CA W/ 1% LIDOCAINE
22-JUL-2008 DE/RX KIT
Bard Reynosa S.A. De C.V.
Reynosa, Tamaulipas Tamaulipas, MX 88000 SWI-DO UPS-0043278-6/1/17
80L--JS GROSHONG NXT, 5 FR DUAL LUMEN W/ 1% LIDOCAINE
22-JUL-2008 DE/RX KIT
Bard Reynosa S.A. De C.V.
Reynosa, Tamaulipas Tamaulipas, MX 88000 SWI-DO UPS-0043278-6/1/18
80L--JS 6FR T/L POWERPICC FULL W/ TLS W/ 1% LIDOCAINE
22-JUL-2008 DE/RX KIT
Antonio Francisco Gandara
Sonora , MX 85010 SWI-DO AE3-0388024-7/1/1
24FFC08 BINS JALAPENO PEPPERS
22-JUL-2008 SALMONELLA
Aaron Manuel Rochin Gallardo
Tijuana Baja California , MX 22340 SWI-DO N55-0136208-5/4/1
16IGT45 Frozen smoked tuna
22-JUL-2008 INSANITARY
Tamarindos Selectos De Colima
Colima, Col , MX 30505 SWI-DO 175-1881081-1/1/1
21SYB14 FRESH TAMARIND
22-JUL-2008 FILTHY
LACKS FIRM
Productos Avila Sa De Cv
Guadalajara JAL, MX 44350 NYK-DO BNI-0010247-3/2/1
33AGT06 PEANUT BRITTLE CANDY
23-JUL-2008 AFLATOXIN
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO BRQ-0032659-6/1/1
53YD-99 POND'S CLARANT B3 w/ UV FILTER 100 G
23-JUL-2008 UNAPPROVED
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO BRQ-0032659-6/1/2
53YD-99 POND'S H Moisturizing Cream w/ Sunscreen Protector 200 G
23-JUL-2008 UNAPPROVED
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO BRQ-0032659-6/1/3
53YD-99 POND'S CLARANT B3 w/ UV FILTER 50 G
23-JUL-2008 UNAPPROVED
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO BRQ-0032659-6/1/4
53YD-99 POND'S CLARANT B3 w/ UV FILTER 200 g
23-JUL-2008 UNAPPROVED
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO BRQ-0032659-6/1/5
53YD-99 POND's H Moisturizing Cream with Sunscreen Protector 400 g
23-JUL-2008 UNAPPROVED
Grande Produce
Jimenez , MX 67450 SWI-DO DR4-0122135-0/2/1
24FFC08 Fresh Jalapeno Peppers
24-JUL-2008 SALMONELLA
ASESORIA Y SERVICIOS ALA S.A. DE C.V.
Reynosa MX-TAM, MX 88630 SWI-DO 861-0129897-3/4/1
24FGC08 FRESH POBLANO PEPPER
24-JUL-2008 PESTICIDE
Unipharm De Mexico, S.A. De C.V.
Veracruz , MX 91697 CIN-DO UPS-1614353-7/1/1
66VCA99 NEUROL , RX, NO ID, PER USE
25-JUL-2008 UNAPPROVED
Cayuni Cosmeticos
Mexico , MX SWI-DO BKM-0017508-3/1/5
53LD-09 BELAYAA Facial Cream with SPF20
25-JUL-2008 NOT LISTED
Malabar Productos Naturales, Sa Ce Cv
Guadalupe , MX SWI-DO CAV-0001522-2/1/1
31KFH99 CHAMOMILE TEA
25-JUL-2008 SALMONELLA
Malabar Productos Naturales, Sa Ce Cv
Guadalupe , MX SWI-DO CAV-0001522-2/1/2
31PFH04 CHAMOMILE TEA
25-JUL-2008 SALMONELLA
Conficorp Sa De Cv
Tepozotian , MX SWI-DO K83-0103709-0/2/1
28BHH08 CHILI POWDER
25-JUL-2008 FILTHY
Productos Karla S A De C V
Zacatecas Jalisco, MX SWI-DO WC1-8242451-3/1/3
33SGT06 APPLE FLAVORED CARAMEL LOLLIPOP W/ CHILI
25-JUL-2008 FILTHY
Productos Karla S A De C V
Zacatecas Jalisco, MX SWI-DO WC1-8242451-3/1/1
33LGT07 MANGOMIS HOT JELLIES W/ CHILI
25-JUL-2008 FILTHY
FERNANDO R. RUY SANCHEZ
CABORCA MX-SON, MX 83600 SWI-DO G93-0189772-8/1/1
24FFC08 JALAPENO PEPPER RED FULL BIN
25-JUL-2008 SALMONELLA
Agricola Dalong SA de CV
Santa Rosa Tapachula MX-NAY, MX 63731 LOS-DO ND7-0057285-9/1/1
28AGB04 FRESH BASIL
28-JUL-2008 SALMONELLA
Carlos Zubieta Torres
Yurecuaro Michoacan , MX SWI-DO BOQ-0028698-6/1/1
24FFC08 POBLANO PEPPERS 45 BX
28-JUL-2008 PESTICIDE
Carlos Zubieta Torres
Yurecuaro Michoacan , MX SWI-DO BOQ-0028709-1/1/1
24FFC08 POBLANO PEPPERS 390 BXS
28-JUL-2008 PESTICIDE
Carlos Zubieta Torres
Yurecuaro Michoacan , MX SWI-DO BOQ-0028742-2/1/1
24FFC08 POBLANO PEPPERS 392 BX
29-JUL-2008 PESTICIDE
AGRICOLA ZARAGOZA, SA DE CV
ALLENDE MX-NLE, MX 67350 SWI-DO DV1-0097475-2/2/1
24FFC08 250 BXS FRESH SERRANO PEPPER
29-JUL-2008 SALMONELLA
Comercializadora Gofer S.A. de C.V.
Azcapotzalco Mx-Dif, MX 02760 SWI-DO WS7-0029127-1/2/1
03HFT07 ROSCANELAS
29-JUL-2008 SALMONELLA
Comercializadora Gofer S.A. de C.V.
Azcapotzalco Mx-Dif, MX 02760 SWI-DO WS7-0029127-1/4/1
03HFT07 DIAVOLIN
29-JUL-2008 SALMONELLA
Mayra Guzman Alvarado
Morelia, Michoacan , MX SWI-DO BOQ-0028760-4/2/1
24FFC08 POBLANO PEPPERS 476 BXS
29-JUL-2008 PESTICIDE
Agropecuaria del Consuelo S.A. de C.V.
Meoqui MX-CHH, MX 33130 SWI-DO 328-0926222-6/1/1
24FFB08 FRESH JALAPENO PEPPERS IN CASES
29-JUL-2008 SALMONELLA
Aventis Pharma S.A De Cv
Ocoyoacac , MX 57740 SWI-DO AEG-2009881-1/7/1
54ACL01 ADerogyl 15
30-JUL-2008 NOT LISTED
Aventis Pharma S.A De Cv
Ocoyoacac , MX 57740 SWI-DO AEG-2009881-1/10/1
61WBR39 Ting Anti-Fungal and Anti-Bacterial Powder
30-JUL-2008 NOT LISTED
Aventis Pharma S.A De Cv
Ocoyoacac , MX 57740 SWI-DO AEG-2009881-1/8/1
61WBJ03 Ting Anti- Fungal and Anti-Bacterial Cream
30-JUL-2008 NOT LISTED
Bayer de Mexico, S.A. de C.V.
Alemania , MX SWI-DO AEG-2009881-1/5/1
61WAJ04 Canesten Clotrimazole Cream 1%
30-JUL-2008 NOT LISTED
Panasonic De Mexico S.A. De C.V.
Ixtapaluca , MX FLA-DO 406-0418756-3/1/1
94R--BB COLOR TV SET - FOR EXPORT ONLY
31-JUL-2008 NON STD
Botanas y Derivados S.A. de C.V.
Guadalupe Mx-Nle, MX 67180 SWI-DO ANG-0015678-7/1/9
07BGT02 CAJA CHARRONES
31-JUL-2008 UNSAFE COL
Botanas y Derivados S.A. de C.V.
Guadalupe Mx-Nle, MX 67180 SWI-DO ANG-0015581-3/1/4
07BGT99 CHARRONES
31-JUL-2008 UNSAFE COL
Comercializadorea Angel Salvador, Sa De Cv
San Jose del Cabo Mx-Bcs, MX 23427 LOS-DO EML-0103679-1/1/1
28AFC04 FRESH BASIL OCIMUM BASILICUM
31-JUL-2008 SALMONELLA
Comercializadorea Angel Salvador, Sa De Cv
San Jose del Cabo Mx-Bcs, MX 23427 LOS-DO EML-0103679-1/2/1
28AFC04 FRESH BASIL OCIMUM BASILICUM
31-JUL-2008 SALMONELLA
Comercializadorea Angel Salvador, Sa De Cv
San Jose del Cabo Mx-Bcs, MX 23427 LOS-DO EML-0103786-4/1/1
28AFC04 FRESH BASIL OCIMUM BASILICUM
31-JUL-2008 SALMONELLA
Comercializadorea Angel Salvador, Sa De Cv
San Jose del Cabo Mx-Bcs, MX 23427 LOS-DO EML-0103786-4/2/1
28AFC04 FRESH BASIL OCIMUM BASILICUM
31-JUL-2008 SALMONELLA
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO M42-3136354-8/1/3
33SGT99 HARD CANDY TAMARIND FLAVOR/ RELLERINDO 24/700G
31-JUL-2008 FILTHY
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO M42-3136354-8/1/5
33SGT06 LOLLIPOP/ PALETAS VERO MANGO 24/640
31-JUL-2008 FILTHY
Aventis Pharma S.A De Cv
Ocoyoacac , MX 57740 SWI-DO AEG-2009913-2/3/1
61WBJ03 BODY CREAM, 1CTN-100/CTN-28GM/PC
31-JUL-2008 NOT LISTED
Mead Johnson De Mexico Sa De Cv
Mexico 1 Df , MX SWI-DO AEG-2009913-2/5/1
60LBA99 PAIN RELIEVER/FEVER REDUCER, 1CTN-22PCS/CTN-100TABLETS/PC
31-JUL-2008 NOT LISTED
Sweets'n Lolly-Pops S. de R. L. de C.V.
Guadalajara JAL, MX 44220 SWI-DO BRQ-0031464-2/1/11
33SGT06 LOLLIPOP GRANDES BOLAS DE FUEGO HARD CANDY
31-JUL-2008 FILTHY
Dulces Topi Sa De Cv
Tonala , MX 45400 SWI-DO BRQ-0032056-5/1/7
33SGT06 E-lotitos Lollipops w/ chile and salt
31-JUL-2008 FILTHY
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO M42-3136359-7/1/2
33SGT06 PALETA VERO MANGO- LOLLIPOPS
31-JUL-2008 FILTHY
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO M42-3136359-7/1/3
33SGT99 RELLERINDO - HARD CANDY TAMARIND FLAVOR
31-JUL-2008 FILTHY
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BRQ-0031430-3/1/1
33EGT06 RELLERINDO CARAMEL HARD CANDY
31-JUL-2008 FILTHY
Dulces Vero, S.A. de C.V
Guadalajara, Jalisco Jalisco, MX 44940 SWI-DO BRQ-0031430-3/1/4
33LGT99 PICA GOMA FRESA FLAVOR SOFT CANDY
31-JUL-2008 FILTHY