Refusal Actions by FDA as Recorded in OASIS for India

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Kishor Spices Company Cochin , IN DET-DO F57-2772208-7/6/1 28BFT54 BLACK PEPPER 01-NOV-2007 FILTHY Ambika Foods Chennai , IN 600028 SWI-DO D52-8900109-6/9/1 03HGT99 AMBIKA WAFERS 01-NOV-2007 FILTHY NO ENGLISH NUTRIT LBL Nhc Exports Corporation Mumbai , IN SWI-DO U52-1606931-5/1/1 28BYT54 BLACK PEPPER WHOLE 01-NOV-2007 SALMONELLA Nhc Exports Corporation Mumbai , IN SWI-DO U52-1606931-5/8/1 21TYT14 TAMARIND SLAB 01-NOV-2007 FILTHY Nhc Exports Corporation Mumbai , IN SWI-DO U52-1606931-5/8/2 21TYT14 TAMARIND SLAB 01-NOV-2007 FILTHY Frespo Food Products Cuttack , IN SWI-DO U52-1606931-5/9/1 21TYT14 TAMARIND CONCENTRATE 01-NOV-2007 FILTHY Frespo Food Products Cuttack , IN SWI-DO U52-1606931-5/9/2 21TYT14 TAMARIND CONCENTRATE 01-NOV-2007 FILTHY Muhi Trading Corporation Mumbai , IN 400023 NYK-DO H77-0107593-6/1/1 62KAC10 OMEPRAZOLE 02-NOV-2007 NOT LISTED UNAPPROVED Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 NYK-DO W04-0054957-6/27/1 36BCE09 THANDAI KESARIA 02-NOV-2007 UNSAFE COL Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 NYK-DO W04-0054957-6/26/1 36BCE09 BADAM KESARIA 02-NOV-2007 UNSAFE COL Nani Agro Foods P Ltd. Erode , IN SWI-DO DY2-0709100-9/1/7 28FGT99 Green Mukhwas 02-NOV-2007 UNSAFE COL COLOR LBLG Nani Agro Foods P Ltd. Erode , IN SWI-DO DY2-0709100-9/1/8 28FGT99 Red Mukhwas 02-NOV-2007 UNSAFE COL COLOR LBLG Inventa Chemicals Ltd Hyderabad , IN NYK-DO H77-0107531-6/1/1 61HDS03 A-BACTERIAL PT. III (NOT ANTIBIOTIC) HUMAN - RXCOMBINATION I 02-NOV-2007 NOT LISTED K.K.R. Food Products Kerala , IN NYK-DO F32-0120782-4/6/1 21TFP14 FRUITS PRESERVE 02-NOV-2007 FILTHY Zephyr Biomedicals Goa , IN 40372 NOL-DO 112-8832447-0/1/1 91N--ED 905865652282-MALARIA TEST KIT 05-NOV-2007 NOT LISTED REGISTERED P. J. Exports Kalher Village In-Mh, IN 421302 NYK-DO AGT-0003546-0/11/1 28FFH99 INDIAN SPICE Partial Refusal 05-NOV-2007 SALMONELLA SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/17/1 21TYT05 CUT MANGO PICKLE 05-NOV-2007 LIST INGRE PRESRV LBL PESTICIDES NUTRIT LBL SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/18/1 21TYT05 AVAKKAI MANGO PICKLE 05-NOV-2007 LIST INGRE PRESRV LBL PESTICIDES NUTRIT LBL SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/19/1 21TYT05 MANG THOKKU PICKLE 05-NOV-2007 LIST INGRE PRESRV LBL PESTICIDES NUTRIT LBL SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/20/1 25YYT99 MIXED VEGETABLE PICKLE 05-NOV-2007 LIST INGRE PRESRV LBL PESTICIDES NUTRIT LBL SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/21/1 24TYT99 SOUR LEAF PICKLE/GONGURA THOKKU PICKLEY 05-NOV-2007 LIST INGRE PRESRV LBL PESTICIDES NUTRIT LBL SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/22/1 24TYT99 MINT LEAF/PUDHINA THOKKU PICKLE 05-NOV-2007 LIST INGRE PRESRV LBL PESTICIDES NUTRIT LBL M K Agro Exports Mumbai , IN 400070 LOS-DO WUG-0125996-8/27/1 21RGT14 TAMARIND SAUCE 05-NOV-2007 FILTHY SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/23/1 21TYT05 TENDER MANGO PICKLE 05-NOV-2007 LIST INGRE PRESRV LBL PESTICIDES NUTRIT LBL P.J. Exports Mumbai , IN 400 009 LOS-DO WUG-0125408-4/9/1 29BCT99 FANTA 05-NOV-2007 UNSAFE COL Ravi Spice Processors Pvt. Ltd. Bangalore In-Ka, IN 560039 LOS-DO WUG-0124581-9/3/1 25ECI99 Tamarind 05-NOV-2007 FILTHY Ravi Spice Processors Pvt. Ltd. Bangalore In-Ka, IN 560039 LOS-DO WUG-0124581-9/16/1 28GGP99 Tamarind 05-NOV-2007 FILTHY Ravi Spice Processors Pvt. Ltd. Bangalore In-Ka, IN 560039 LOS-DO WUG-0124581-9/16/2 28GGP99 Tamarind 05-NOV-2007 FILTHY Thakar Exports Trinagar-Delhi , IN 110035 CHI-DO 300-1452419-1/14/1 07BAT99 PLAIN MATHRI 05-NOV-2007 FILTHY Thakar Exports Trinagar-Delhi , IN 110035 CHI-DO 300-1452419-1/16/1 66VBL99 SWEET MATHRI 05-NOV-2007 MFR INSAN Gayatri Masala Exporter Nadiad IN-GJ, IN 387001 LOS-DO WUG-0123852-5/8/1 53CY-02 KAJAL 05-NOV-2007 COSM COLOR Thakar Exports Trinagar-Delhi , IN 110035 CHI-DO 300-1452419-1/15/1 07BAT99 GHEVER SMALL 05-NOV-2007 FILTHY SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO 322-6545324-4/31/1 28BFT99 MIXED SPICE POWDER/RASAM POWDER 05-NOV-2007 NUTRIT LBL SALMONELLA Gayatri Masala Exporter Nadiad IN-GJ, IN 387001 LOS-DO WUG-0123852-5/20/3 28BGH15 CORIANDER POWDER 05-NOV-2007 SALMONELLA Shree Baidyanath Ayurved Bhawan Ltd Jhansi , IN LOS-DO WUG-0123192-6/16/2A 66VAF99 GUGGULU 05-NOV-2007 NOT LISTED UNAPPROVED Colgate Palmolive (India) Ltd Mumbai , IN 400076 LOS-DO WUG-0123192-6/16/2B 66VBJ99 HERBAL TOOTHPASTE 05-NOV-2007 UNAPPROVED Eastern Condiments Pvt. Ltd. Kerala , IN NYK-DO F32-0120799-8/2/1 24HGH04 CHILLY 05-NOV-2007 BACTERIA Choice Laboratories Unjha GJ, IN 384170 NYK-DO 739-6134895-7/1/1 56YBJ99 TRIPLE ANTIBIOTIC CREAM 05-NOV-2007 NOT LISTED UNAPPROVED Ravi Spice Processors Pvt. Ltd. Bangalore In-Ka, IN 560039 SAN-DO 484-1010411-0/1/4 07BGT06 POTATO CHIPS 05-NOV-2007 LIST INGRE LACKS N/C NUTRIT LBL Ravi Spice Processors Pvt. Ltd. Bangalore In-Ka, IN 560039 SAN-DO 484-1010411-0/2/1 07BGT99 MASALA KUR KURE 05-NOV-2007 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 SAN-DO BZJ-1071209-7/10/1 07AGT99 NAVRATTAN-HOT DELICACY 05-NOV-2007 SALMONELLA Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 SAN-DO BZJ-1071209-7/33/1 07AGT99 NAVRATTAN-HOT DELICACY 05-NOV-2007 SALMONELLA Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 SAN-DO BZJ-1071209-7/63/1 07AGT99 PANCHRATTAN-DRY POTATO 05-NOV-2007 LIST INGRE LACKS N/C Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 SAN-DO BZJ-1071209-7/76/1 30YHY99 BADAM KESARIA-FRUIT JUICE (12 BO) 05-NOV-2007 LIST INGRE LACKS N/C Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 SAN-DO BZJ-1071209-7/77/1 30YHY99 THANDAI KESARIA-FRUIT JUICE (12 BO) 05-NOV-2007 UNSAFE COL LIST INGRE Aurobindo Pharma Ltd Hyderebad , IN 500038 FLA-DO T94-0047018-1/1/1 56BCZ03 AMOXICILLIAN 06-NOV-2007 UNAPPROVED Aurobindo Pharma Ltd Hyderebad , IN 500038 FLA-DO T94-0047018-1/2/1 56BCZ03 AMOXICILLIAN 06-NOV-2007 UNAPPROVED Aurobindo Pharma Ltd Hyderebad , IN 500038 FLA-DO T94-0047018-1/3/1 56BCZ03 AMOXICILLIAN 06-NOV-2007 UNAPPROVED Venus Remedies Ltd Haryana , IN SAN-DO AEK-6733109-6/1/1 62GIK99 NATRACEUTRAICAL HERBAL 06-NOV-2007 NOT LISTED UNAPPROVED Colgate-Palmolive (India) Ltd. Baddi Himachal Pradesh, IN 174103 CHI-DO KM6-0104714-5/5/1 63RBY06 Herbal Toothpaste w/ sodium monofluorophosphate 07-NOV-2007 NOT LISTED LACKS N/C Southern Drugs & Pharmaceuticals Dowlaishwaram , IN 533 125 (A.P.) CHI-DO KM6-0104714-5/11/1 65RBZ18 ENO (BOTTLE) 07-NOV-2007 NOT LISTED NO ENGLISH Avee Art And Craft New Delhi , IN 110018 NOL-DO 112-0032416-1/1/1 52AID26 942604038901 BRASS CUP 07-NOV-2007 UNSAFE ADD Avee Art And Craft New Delhi , IN 110018 NOL-DO 112-0032416-1/5/1 86H--QG 942604038901 EYE GLASSES 07-NOV-2007 NOT LISTED Kay Kay Exports Cochin , IN LOS-DO AQZ-0253935-4/1/1 16MGT03 FROZEN SQUID TUBES AND TENTACLES 07-NOV-2007 SALMONELLA Sahajanand Laser Gujrat , IN CHI-DO 101-7616493-6/1/1 95R--FE LASET CUTTING MACHINE FOR FABTECH 2007 TRADE SHOW EXHIBITION 07-NOV-2007 NON STD Unique Fragrances Delhi D, IN 110034 SAN-DO AYG-1001215-6/38/1 28AGT15 CORIANDER WHOLE SPICES 07-NOV-2007 FILTHY M K Agro Exports Mumbai , IN 400070 SAN-DO WUG-0138588-8/6/4 37KCT23 DATE & TAMARIND CHUTNEY 07-NOV-2007 FILTHY P. Mittulaul Lalah And Sons Chennai , IN 600029 NYK-DO 300-2224834-6/10/1 28FEF04 CURRY POWDER 08-NOV-2007 SALMONELLA Contacare Ophthalmics & Diagnostics Gujarat , IN 391440 SWI-DO GH5-0034780-8/1/1 86L--WL TRYPTAN BLUE for Intraocular Use. 08-NOV-2007 NOT LISTED REGISTERED Polymer Technologies International Gujarat , IN SWI-DO GH5-0034913-5/1/1 86K--YB INTRA OCULAR LENSES 08-NOV-2007 NOT LISTED REGISTERED Vicco Laboratories (Goa) Goa , IN SWI-DO KM6-0104872-1/2/1 63RBJ99 TOOTH PASTE 09-NOV-2007 UNAPPROVED Vicco Laboratories (Goa) Goa , IN SWI-DO KM6-0104872-1/2/2 63SBO99 TOOTH PASTE 09-NOV-2007 UNAPPROVED KITCHEN XPRESS OVERSEAS LIMITED Gandhinagar Gujarat, IN 382721 SWI-DO 411-8161772-5/5/3 28BGT08 CHILLI POWDER WHITE 13-NOV-2007 SALMONELLA Hindustan Coca Cola Beverages PVT LTD Thane , IN SWI-DO KM6-0104872-1/6/1A 29BCT06 FANTA SODA 13-NOV-2007 LIST INGRE COLOR LBLG Nekkanti Sea Foods Ltd. Andhra Pradesh AP, IN 530002 NYK-DO 991-0157638-9/1/1 16JFD05 FROZEN SHELLON SHRIMP 13-NOV-2007 SALMONELLA TEMPTATION FOODS LIMITED MUMBAI In-Mh, IN 400004 SAN-DO K80-0940348-7/3/7 24TGD25 FROZEN VEGETABLES / PALAK (INDIAN SPINACH) 13-NOV-2007 PESTICIDE Aadivighnesh Chem PVT. LTD. Mumbai 400092 , IN 400092 NYK-DO 112-8164828-9/1/1 56OIY05 919210155513 ENROFLOXACIN 13-NOV-2007 NEW VET DR Laljee Godhoo & Co. Andheri (E), Mumbai , IN DET-DO RE9-0006150-8/1/1 28FHT99 Asafoetida Powder (Spice) 14-NOV-2007 SALMONELLA Laljee Godhoo & Co. Andheri (E), Mumbai , IN DET-DO RE9-0006150-8/2/1 28FHT99 ASAFOETIDA POWDER (Spice) 14-NOV-2007 SALMONELLA Shakti International Gulab Bari, Katghar Moradabad , IN NYK-DO 557-1013805-2/2/1 52AID26 BRASS BATHROOM TUMBLER 14-NOV-2007 UNSAFE ADD Capital Foods Limited Mumbai , IN 400 013 CHI-DO J89-0086756-7/2/1 24FGT02 BHINDI OKRA 14-NOV-2007 PESTICIDES Good-Day Foods Ltd. Thane IN-MH, IN 400604 SAN-DO AYG-1001199-2/10/1 07BET99 PETHA RANI SNACK FOOD 14-NOV-2007 NO PROCESS Good-Day Foods Ltd. Thane IN-MH, IN 400604 SAN-DO AYG-1001199-2/11/1 07BET99 PETHA RANI SNACK FOOD 14-NOV-2007 NO PROCESS Capital Foods Limited Mumbai , IN 400 013 CHI-DO J89-0086729-4/2/1 24FGT02 BHINDI CUT OKRA 14-NOV-2007 PESTICIDES Capital Foods Limited Mumbai , IN 400 013 CHI-DO J89-0086729-4/2/2 24FGT02 BHINDI OKRA 14-NOV-2007 PESTICIDES TEMPTATION FOODS LIMITED MUMBAI In-Mh, IN 400004 CHI-DO 300-1452200-5/15/1 24TCP25 PALAK/SPINACH 14-NOV-2007 PESTICIDES Target Logistiics Vijayawada , IN 520001 NOL-DO 112-6774122-3/1/1A 53LD-99 Cosmetics 14-NOV-2007 COSMETLBLG Target Logistiics Vijayawada , IN 520001 NOL-DO 112-6774122-3/1/1B 65LBJ99 Sunscreen 14-NOV-2007 NOT LISTED Target Logistiics Vijayawada , IN 520001 NOL-DO 112-6774122-3/1/1C 66VCA99 Drug Products 14-NOV-2007 COL ADDED UNAPPROVED J. D. Corporation Mumbai , IN LOS-DO WUG-0139181-1/17/1 66VBY99 DABAR CHYAVANAPRASH 15-NOV-2007 UNAPPROVED J. D. Corporation Mumbai , IN LOS-DO WUG-0139181-1/17/2 66VBY99 DABAR CHYAVANAPRASH 15-NOV-2007 UNAPPROVED J. D. Corporation Mumbai , IN LOS-DO WUG-0139181-1/17/3 66VBY99 Dabur Chyawanprash 15-NOV-2007 UNAPPROVED J. D. Corporation Mumbai , IN LOS-DO WUG-0139181-1/45/1 66VBL99 GRIPE WATER 15-NOV-2007 UNAPPROVED Suvarna Rekha Marines Pvt., Ltd./aka Suarna Rekha Exports Visakhapatnam In-Ap, IN 530002 LOS-DO ROD-0000383-4/1/1 16XGD21 FRZ H/LESS S/ON BLK TIGER SHRIMP/13-15 15-NOV-2007 FILTHY Suvarna Rekha Marines Pvt., Ltd./aka Suarna Rekha Exports Visakhapatnam In-Ap, IN 530002 LOS-DO ROD-0000383-4/2/1 16XGD21 FRZ H/LESS S/ON BLK TIGER SHRIMP/16-20 15-NOV-2007 FILTHY Suvarna Rekha Marines Pvt., Ltd./aka Suarna Rekha Exports Visakhapatnam In-Ap, IN 530002 LOS-DO ROD-0000383-4/3/1 16XGD21 FRZ H/LESS S/ON BLK TIGER SHRIMP/21-25 15-NOV-2007 FILTHY Suvarna Rekha Marines Pvt., Ltd./aka Suarna Rekha Exports Visakhapatnam In-Ap, IN 530002 LOS-DO ROD-0000383-4/4/1 16XGD21 FRZ H/LESS S/ON BLK TIGER SHRIMP/26-30; cold storage lot #51 15-NOV-2007 FILTHY Suvarna Rekha Marines Pvt., Ltd./aka Suarna Rekha Exports Visakhapatnam In-Ap, IN 530002 LOS-DO ROD-0000383-4/5/1 16XGD21 FRZ H/LESS S/ON BLK TIGER SHRIMP/31-40 15-NOV-2007 FILTHY Haldiram Exports (Pvt) Limited New Delhi IN-DL, IN 110044 NYK-DO W04-0055645-6/4/1 07BGT99 BHELPURI,PANIPURE 15-NOV-2007 SALMONELLA SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO EG6-7239589-4/17/1 21THT14 Tamarind Sambar Paste 19-NOV-2007 FILTHY NUTRIT LBL SGR (777) Foods Pvt. Ltd. Chennai In-Tn, IN 600001 DET-DO EG6-7239589-4/28/1 21THT14 Tamarind Rice Paste 19-NOV-2007 FILTHY NUTRIT LBL Homeopathic Clinic Ludhiana , IN NOL-DO 112-7143889-9/1/1 66VDA99 857260588276/HOMEOPATIC MEDICINE 20-NOV-2007 DIRECTIONS DRUG NAME Unique Fragrances Delhi D, IN 110034 SAN-DO AYG-1001301-4/118/1 62MAO99 PREMIUM CAMPHOR 20-NOV-2007 NOT LISTED Unique Fragrances Delhi D, IN 110034 SAN-DO AYG-1001301-4/119/1 62MAO99 PREMIUM CAMPHOR 20-NOV-2007 NOT LISTED Unique Fragrances Delhi D, IN 110034 SAN-DO AYG-1001301-4/120/1 62MAO99 PREMIUM CAMPHOR 20-NOV-2007 NOT LISTED Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/1/1 25PEE99 WHOLE MUSHROOMS 21-NOV-2007 NUTRIT LBL NEEDS FCE NO PROCESS BRITANNIA INDUSTRIES LIMITED KOLKATA IN-WB, IN 700 017 SEA-DO 906-0457942-6/22/1 03JGY09 BRITANIA ORANGE CREAM COOKIES 23-NOV-2007 UNSAFE COL LIST INGRE LABELING NUTRIT LBL BRITANNIA INDUSTRIES LIMITED KOLKATA IN-WB, IN 700 017 SEA-DO 906-0457942-6/25/1 03HGY09 BRITANIA GOODDAY PISTABADAM COOKIES 23-NOV-2007 UNSAFE COL LIST INGRE LABELING NUTRIT LBL BRITANNIA INDUSTRIES LIMITED KOLKATA IN-WB, IN 700 017 SEA-DO 906-0457942-6/27/1 03JGY10 BRITANIA ORANGE CREAM TREAT COOKIE 23-NOV-2007 UNSAFE COL LIST INGRE LABELING NUTRIT LBL BRITANNIA INDUSTRIES LIMITED KOLKATA IN-WB, IN 700 017 SEA-DO 906-0457942-6/28/1 03JGY09 BRITANIA MANGO TREAT COOKIES 23-NOV-2007 UNSAFE COL LIST INGRE LABELING NUTRIT LBL Ramdev Food Products Pvt. Ltd. Ahmedabad Gujarat, IN 380004 SWI-DO 411-8162106-5/15/2 25YGT99 Bengal Wafer-Small (Colour) 27-NOV-2007 UNSAFE COL LIST INGRE COLOR LBLG NUTRIT LBL Ramdev Food Products Pvt. Ltd. Ahmedabad Gujarat, IN 380004 SWI-DO 411-8162108-1/5/1 28BGT19 GINGER POWDER 27-NOV-2007 SALMONELLA Shasun Chemicals And Drugs Ltd Cuddalore , IN 607005 NYK-DO H77-0107709-8/1/1 62TCU03 NIZATIDINE 27-NOV-2007 DIRECTIONS Aarti Chicki & Snacksjivdani Nivas Mumbai , IN 401209 NYK-DO BMY-3007776-4/3/1 33DGT05 BANSI PEANUT CHIKKI CANDIES 27-NOV-2007 AFLATOXIN J. D. Corporation Mumbai , IN LOS-DO WUG-0139181-1/16/1 53IG-01 Toothpaste Babool (Natural strength for teeth) 28-NOV-2007 NOT LISTED Wendt-Chemie Vertriebsges Mbh & Co. Hamburg , DE 22041 FLA-DO M21-0736654-6/1/1 62KAE10 OMEPRAZOLE "FOR EXPORT ONLY" PLEASE REFUSE 28-NOV-2007 UNAPPROVED Research Pharmaceutical Limited Causeway Bay , HK FLA-DO M21-0736737-9/1/1 62GDL18 DICLOFENAC "FOR EXPORT ONLY" PLEASE REFUSE MERCHANDISE 28-NOV-2007 UNAPPROVED Kohinoor Foods Limited New Delhi , IN NYK-DO KM6-0032816-5/45/1 28BGT08 WHITE CHILLY POWDER 29-NOV-2007 SALMONELLA KAMAL FOODS Mumbai IN-MH, IN 400031 NYK-DO KM6-0033584-8/5/1 66VBL99 WOODWARDS GRIPE WATER 30-NOV-2007 UNAPPROVED KAMAL FOODS Mumbai IN-MH, IN 400031 NYK-DO KM6-0033584-8/38/1 28BGT54 BLACK PEPPER POWDER 30-NOV-2007 FILTHY SALMONELLA