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
KITCHEN XPRESS OVERSEAS LIMITED
Gandhinagar Gujarat, IN 382721 NYK-DO 185-0051376-9/11/1
28FGT99 RANGEELA MUKHWAS - MOUTH FRESHENER
03-DEC-2007 UNSAFE COL
Yogi Ayurvedic Products Private Ltd.
Nashik IN-MH, IN 422007 SWI-DO 411-8162219-6/6/1
21UGT14 Vitaimli - Jeera flavor
04-DEC-2007 FILTHY
INCONSPICU
LABELING
NUTRIT LBL
Yogi Ayurvedic Products Private Ltd.
Nashik IN-MH, IN 422007 SWI-DO 411-8162219-6/6/2
21UGT14 Vitaimli - Sunth Flavor
04-DEC-2007 FILTHY
INCONSPICU
LABELING
NUTRIT LBL
Yogi Ayurvedic Products Private Ltd.
Nashik IN-MH, IN 422007 SWI-DO 411-8162219-6/6/3
21UGT14 Vitaimli - Saunf Flavor
04-DEC-2007 FILTHY
INCONSPICU
LABELING
NUTRIT LBL
Yogi Ayurvedic Products Private Ltd.
Nashik IN-MH, IN 422007 SWI-DO 411-8162219-6/6/4
21UGT14 Vitaimli Jeera Flavour Candy - Jar
04-DEC-2007 FILTHY
INCONSPICU
LABELING
NUTRIT LBL
Yogi Ayurvedic Products Private Ltd.
Nashik IN-MH, IN 422007 SWI-DO 411-8162219-6/6/5
21UGT14 Vitaimli Sunth Flavour Candy - Jar
04-DEC-2007 FILTHY
INCONSPICU
LABELING
NUTRIT LBL
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/14/1
27YCE03 Bombay Bhel-Puri Chutney with Tamarind Paste
04-DEC-2007 FILTHY
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/14/4
27YGT03 PAKODA CHUTNEY
04-DEC-2007 FILTHY
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/14/5
27YGT03 SAMOSA CHUTNEY
04-DEC-2007 FILTHY
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/15/1
37JCT99 DELHI KI CHAT
04-DEC-2007 FILTHY
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/16/1
21WCE14 TAMARIND DATE SAUCE
04-DEC-2007 FILTHY
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/16/2
37JCE99 Pani Puri Concentrate with Tamarind
04-DEC-2007 FILTHY
Capital Foods Limited
Thane , IN 421304 SWI-DO 411-8162219-6/7/3
13GGT02 VANILLA CUSTARD POWDER
04-DEC-2007 UNSAFE COL
COLOR LBLG
Capital Foods Limited
Thane , IN 421304 SWI-DO 411-8162219-6/7/4
13BGT99 Kesar Elaichi Custard Powder
04-DEC-2007 UNSAFE COL
COLOR LBLG
NO ENGLISH
Capital Foods Limited
Thane , IN 421304 SWI-DO 411-8162219-6/8/1
20CCT14 Strawberry Jelly Crystals
04-DEC-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
NO ENGLISH
Capital Foods Limited
Thane , IN 421304 SWI-DO 411-8162219-6/9/1
20CCT13 Raspberry Jelly Crystals
04-DEC-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
NO ENGLISH
Capital Foods Limited
Thane , IN 421304 SWI-DO 411-8162219-6/11/1
35AFT01 Jelly Crystal - Pineapple Flavored
04-DEC-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
NO ENGLISH
Capital Foods Limited
Thane , IN 421304 SWI-DO 411-8162219-6/12/1
35AFT01 Jelly Crystal - Orange Flavor
04-DEC-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
NO ENGLISH
Thakar Exports
Trinagar-Delhi , IN 110035 CHI-DO 300-1452419-1/18/1
66VBL99 KAYAM CHURAN
04-DEC-2007 NOT LISTED
LACKS N/C
V.N. Surendran
Kerala , IN 695146 CIN-DO AEK-9053293-4/1/1
65VCA13 SIZOPIN 100 MG
04-DEC-2007 UNAPPROVED
V.N. Surendran
Kerala , IN 695146 CIN-DO AEK-9053293-4/1/2
41GYY99 DUTIN 20 MG
04-DEC-2007 UNAPPROVED
Mahashian Di Hatti Ltd.
New Delhi IN-DL, IN 110015 SEA-DO 110-8560597-2/2/3
28KGT99 KITCHEN KING MASALA
05-DEC-2007 SALMONELLA
Punjabi Ghasitaram Halwai P
India , IN NYK-DO BMY-3007776-4/5/1
03RET99 GHASITARAM RASS MALAI
05-DEC-2007 NEEDS FCE
MAXROTH CHEMICALS
AHMEDABAD IN-GJ, IN 380009 NYK-DO H67-1303021-0/3/1
02DAH07 BASMATI RICE
05-DEC-2007 FILTHY
MAXROTH CHEMICALS
AHMEDABAD IN-GJ, IN 380009 NYK-DO H67-1303021-0/5/1
02DAH07 BASMATI RICE
05-DEC-2007 FILTHY
Dr. Kalyan Banerjee
New Delhi, India , IN 110019 NOL-DO 112-0148283-6/1/1
66VIP99 949037233743/HOMEOPATIC
05-DEC-2007 DIRECTIONS
DR QUALITC
LACKS FIRM
Ms Keshav Exports Pvt Lts
Bangalore , IN NYK-DO DP4-0416514-5/2/2
24UCE99 KASURI METHI
06-DEC-2007 SALMONELLA
Sakthi Masala Private Limited
Erode,Tamil Nadu In-Tn, IN 638004 NYK-DO KM6-0034884-1/3/1
28BGT15 CORIANDER POWDER
06-DEC-2007 SALMONELLA
Munnilal India Pvt Ltd.,
Rohini Delhi , IN NYK-DO EL0-0222804-6/11/1
52AMD99 ANGITHI COPPER & BRASS
06-DEC-2007 UNSAFE ADD
H. S. Bajaj & Sons (Bombay) Pvt. Ltd.
Chennai IN-TN, IN 600010 SWI-DO 450-0170791-3/1/1
28AAY12 INDIAN CELERY SEED
07-DEC-2007 SALMONELLA
Keshav Exports Private Limited
Bangalore , IN 560 061 CHI-DO 300-1452579-2/14/1
03MGY99 AMBIKA WAFFERS
07-DEC-2007 FILTHY
CAPITAL FOODS EXPORTTS PRIVATE LIMITED
KUTCH IN-GJ, IN 370230 ATL-DO BMK-0605965-1/1/1
23BGD05 COCONUT SHREDDED
07-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO AYG-1001306-3/48/1
62MAO99 CAMPHOR
07-DEC-2007 NOT LISTED
Aurolab
Madurai, Tamil Nadu , IN 625-020 NOL-DO 112-0198607-5/1/1
79G--AR 857455156769/SYNTHETIC SUTURE
07-DEC-2007 REGISTERED
Mtr International
Ii Stage, Bangalore , IN 560070 SWI-DO KM6-0103821-9/1/11
37BGT99 ALMOND MIX
10-DEC-2007 YELLOW #5
Glenmark Pharmaceu
Colvale , IN NOL-DO 112-0246256-3/1/1
65JDB24 860302809567/NORETHINDRONE & ETHINYL EST
10-DEC-2007 NOT LISTED
UNAPPROVED
Jayco Chemical Industries
Mumbai Mahara, Shira, IN 401104 PHI-DO 336-8078611-1/1/1
66SCS08 ISOXSUPRINE HCL (VASODILATOR);HUMAN - RX/SINGLE INGREDIENT;A
10-DEC-2007 DIRECTIONS
M/S Handmade Collections Exportl-123a, Laxmi Nagar
Delhi , IN 110092 NOL-DO 112-0256877-3/1/1
53CH-07 858057664519/HENNA PASTE
10-DEC-2007 UNSAFE COL
CSTIC LBLG
Zydus Cadilla
Dabhasa Padra , IN NOL-DO 112-0478432-9/1/1
66MCA36 927735713335-HALOPERIDOL 10 MG
11-DEC-2007 NOT LISTED
Zydus Cadilla
Dabhasa Padra , IN NOL-DO 112-0478432-9/1/2
66MCA36 927735713335-HALPERIDOL 20 MG
11-DEC-2007 NOT LISTED
Kohinoor Foods Limited
New Delhi , IN NYK-DO KM6-0034110-1/3/1
28BGT49 TURMERIC POWDER
12-DEC-2007 SALMONELLA
Kohinoor Foods Limited
New Delhi , IN NYK-DO KM6-0034110-1/4/1
28FGR04 MADRAS CURRY POWDER
12-DEC-2007 SALMONELLA
Peermade Development Society
Kerala , IN 685531 NYK-DO 721-2710003-9/1/1
28AFE54 ORGANIC BLACK PEPPER
12-DEC-2007 FILTHY
SALMONELLA
Punjabi Ghasitaram Halwai P
India , IN NYK-DO BMY-3007776-4/5/2
03RET99 GHASITARAM RASSGULLA
12-DEC-2007 NEEDS FCE
J.D. Corporation
Masjid Bunder , IN SAN-DO JM4-0117177-3/2/2
21THT14 Tamarind concentrate
12-DEC-2007 FILTHY
LABELING
NUTRIT LBL
J.D. Corporation
Masjid Bunder , IN SAN-DO JM4-0117177-3/7/2
07AGT99 MUKHWAS SNACK
12-DEC-2007 INCONSPICU
J.D. Corporation
Masjid Bunder , IN SAN-DO JM4-0117177-3/7/1
07AGT99 MUKHWAS SNACK
12-DEC-2007 INCONSPICU
J.D. Corporation
Masjid Bunder , IN SAN-DO JM4-0117177-3/7/3
07AGT99 MUKHWAS SNACK
12-DEC-2007 INCONSPICU
J.D. Corporation
Masjid Bunder , IN SAN-DO JM4-0117177-3/6/3
29ACT04 FANTA DRINK
12-DEC-2007 LIST INGRE
LABELING
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/1
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/2
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/3
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/4
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/5
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/6
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/7
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/2/8
28GGT99 RED CHILI POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/4/1
28BGT49 TUMERIC POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/4/2
28BGT49 TUMERIC POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/4/3
28BGT49 TUMERIC POWDER
13-DEC-2007 SALMONELLA
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 SAN-DO 484-1009728-0/13/1
28BGT54 BLACK PEPPER POWDER
13-DEC-2007 FOREIGN OB
FILTHY
SALMONELLA
Ra India
Maharashtra , IN SAN-DO G05-1127133-3/3/1
37JGE03 RED CHILLY SAUCE
13-DEC-2007 NO PROCESS
Ra India
Maharashtra , IN SAN-DO G05-1127133-3/4/1
37JCT99 GREEN CHILLY SAUCE
13-DEC-2007 NO PROCESS
Ra India
Maharashtra , IN SAN-DO G05-1127133-3/5/1
37JGE05 SOYA SAUCE
13-DEC-2007 NO PROCESS
Ra India
Maharashtra , IN SAN-DO G05-1127133-3/9/1
37JGE05 RED BHEL CHUTNEY
13-DEC-2007 NO PROCESS
Ra India
Maharashtra , IN SAN-DO G05-1127133-3/10/1
37JGE05 GREEN BHEL CHUTNEY
13-DEC-2007 NO PROCESS
Daxal Cosmetics P.Ltd
Tal,Sanand,Dist.Ahmedabad,Gujarat , IN 38221 FLA-DO T94-0047173-4/1/1
53LC-99 SYMBA FAIRNESS CREAM
14-DEC-2007 NOT LISTED
R.S .Lal International
Dehli In-Dl, IN 110052 SAN-DO K80-0937318-5/9/1
18CGT99 SOYA WADI
14-DEC-2007 LIST INGRE
LACKS FIRM
LABELING
NUTRIT LBL
Shreeji Pharma International
Vadodara , IN SEA-DO 112-0282355-8/1/1
60QCS07 939991095644 LIDOCAINE
17-DEC-2007 NOT LISTED
DIRECTIONS
UNAPPROVED
Ms Sangu Impex
Mumbai , IN NYK-DO 541-0230355-6/8/1
28AGT54 WHOLE BLACK PEPPER
17-DEC-2007 FILTHY
SALMONELLA
Ms Sangu Impex
Mumbai , IN NYK-DO 541-0230355-6/9/1
28BGT54 GROUND BLACK PEPPER
17-DEC-2007 FILTHY
SALMONELLA
Food Concerntrates
Bangalore KA, IN 560044 SAN-DO KM6-0103236-0/10/1
21TGT14 PANIPURI PASTES
17-DEC-2007 FILTHY
Adani Food Pvt. Ltd
Rajkot IN-GJ, IN 360002 CHI-DO KM6-0104632-9/23/1
25ECE99 ASSORTED PICKLES
17-DEC-2007 LABELING
NEEDS FCE
Obson International
Mumbai , IN 400053 SAN-DO KM6-0104166-8/6/1
03MGT99 PUNJABI WADI
17-DEC-2007 FILTHY
Venkatesh Foods Industries
Gandhiganj , IN LOS-DO WDA-0019126-7/1/1
21SGH14 TAMARIND POWDER (SPRAY DRIED)
18-DEC-2007 FILTHY
Keshav Exports Private Limited
Bangalore , IN 560 061 NYK-DO KM6-0033544-2/6/1
33YHT99 MILAN MUKHWAS
19-DEC-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
YELLOW #5
Keshav Exports Private Limited
Bangalore , IN 560 061 NYK-DO KM6-0033544-2/6/2
33YHT99 CRANE MUKHWAS
19-DEC-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
LABELING
YELLOW #5
Keshav Exports Private Limited
Bangalore , IN 560 061 NYK-DO KM6-0033544-2/6/3
33YHT99 KUBER MUKHWAS
19-DEC-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
LABELING
Haldiram Foods International Ltd.
Nagpur , IN SWI-DO WBA-3029560-3/1/5
07BGT99 BHUJIA SEV SNACK FOODS W FRIED EXTRUDED LENTIL STICKS
19-DEC-2007 SALMONELLA
KASANA FOODS PVT. LTD
Nagpur , IN SWI-DO WBA-3029560-3/1/6
07BGT99 BHUJIA SEV SNACK FOODS W FRIED EXTRUDED LENTIL STICKS
19-DEC-2007 SALMONELLA
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/17/1
27YCE07 Bombay Sandwich Spread ( Hot)
19-DEC-2007 UNSAFE COL
FILTHY
COLOR LBLG
NEEDS FCE
NO PROCESS
Capital Foods Limited
Jogeshwari (W), Mumbai , IN 400102 SWI-DO 411-8162219-6/17/2
27YCE07 Bombay Sandwich Spread (Mild)
19-DEC-2007 UNSAFE COL
FILTHY
COLOR LBLG
NEEDS FCE
NO PROCESS
MAX FOODS
Navi Mumbai IN-MH, IN 400701 SWI-DO 411-8162219-6/2/3
03EGT09 Crispy Bread
19-DEC-2007 FILTHY
Capital Foods Limited
Nasik , IN SWI-DO 411-8162219-6/16/4
37JCE03 Green Chilli Sauce (430g)
19-DEC-2007 LIST INGRE
PRESRV LBL
LABELING
NUTRIT LBL
Nani Agro Foods P Ltd.
Erode , IN SWI-DO DY2-0709100-9/1/5A
28BGT49 Turmeric Powder (Haldi Powder) 14oz.
20-DEC-2007 LACKS FIRM
SALMONELLA
Nani Agro Foods P Ltd.
Erode , IN SWI-DO DY2-0709100-9/1/5B
28BGT49 Turmeric Powder (Haldi Powder)
20-DEC-2007 LACKS FIRM
SALMONELLA
Bajay Consumer Care Ltd
Medak , IN NOL-DO 112-0584795-0/1/4
66VAY99 920234322139-Baja Kofney Ayurvedic Cough Syrup
20-DEC-2007 DR QUALITC
Sando Beothee Pvt Ltd
Mumbai , IN NOL-DO 112-0584795-0/1/5
66VAY99 920234322139 Sandu Brothers Kanakasav
20-DEC-2007 DR QUALITC
Dubur Indea Ltd
Solan , IN NOL-DO 112-0584795-0/1/3
66VAY99 920234322139-Dabur Arjunarishta (parthadyarishta)
20-DEC-2007 DIRECTIONS
DR QUALITC
Shree Baidyanath Ayurved Bhawan (P) Ltd.
Allahabad IN-UP, IN 211 008 SWI-DO KM6-0104872-1/3/17
53LH-03 MULTANI MITTI
21-DEC-2007 CSTIC LBLG
COSMETLBLG
Ravi Spice Processors Pvt. Ltd.
Bangalore In-Ka, IN 560039 LOS-DO WUG-0140310-3/6/5
07BGT99 PLANTAIN CHIPS
21-DEC-2007 UNSAFE COL
Franco Indian Phrma Ltd
Mumbai , IN NOL-DO 112-0675934-5/1/1
61PCB55 858057634424/GLYCIPHAGE
27-DEC-2007 UNAPPROVED
Evergreen Exports
Mumbai , IN LOS-DO WUG-0140812-8/5/1
28AGH99 AJWAIN
27-DEC-2007 FILTHY
Evergreen Exports
Mumbai , IN LOS-DO WUG-0140812-8/2/2
28BGH15 CORIANDER POWDER
27-DEC-2007 SALMONELLA
FALCON MARINE EXPORTS LTD.,
JAGATSINGHPUR IN-OR, IN 754141 LOS-DO 082-0298922-7/1/1
16XGD21 FRZ RAW H/L S/ON BLACK TIGER SHRIMP SZ 16/20
28-DEC-2007 FILTHY
FALCON MARINE EXPORTS LTD.,
JAGATSINGHPUR IN-OR, IN 754141 LOS-DO 082-0298922-7/2/1
16XGD21 FRZ RAW H/L S/ON BLACK TIGER SHRIMP SZ 26/30
28-DEC-2007 FILTHY
FALCON MARINE EXPORTS LTD.,
JAGATSINGHPUR IN-OR, IN 754141 LOS-DO 082-0298922-7/3/1
16XGD21 FRZ RAW H/L S/ON BLACK TIGER SHRIMP SZ 31/40; cold storage l
28-DEC-2007 FILTHY
Kogta Import Export Pvt Ltd
Jalgaon , IN 425003 DET-DO BGK-0025311-3/6/1
24EGT09 Toor Dal
31-DEC-2007 FILTHY
USUAL NAME
NUTRIT LBL
Haldiram Foods International Ltd.
Nagpur , IN FLA-DO E10-0117361-9/1/1
07BGT99 BHUJIA SNACK
31-DEC-2007 SALMONELLA
Haldiram Foods International Ltd.
Nagpur , IN FLA-DO E10-0117361-9/2/1
07BGT99 BHUJIA
31-DEC-2007 SALMONELLA