Refusal Actions by FDA as Recorded in OASIS for United Arab Emirates
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Sanath Suresh
Dubai , AE NYK-DO AEK-9084313-3/1/1
61PCA26 METFORMIN
08-JAN-2008 UNAPPROVED
Sanath Suresh
Dubai , AE NYK-DO AEK-9084313-3/1/2
61PCA62 PIOGLITAZONE
08-JAN-2008 UNAPPROVED
Sanath Suresh
Dubai , AE NYK-DO AEK-9084313-3/1/3
61PCA99 COMPRID
08-JAN-2008 UNAPPROVED
Sanath Suresh
Dubai , AE NYK-DO AEK-9084313-3/1/4
62OCA05 ALTACE 5 MG
08-JAN-2008 UNAPPROVED
UNKNOWN MANUFACTURER
UNKNOWN , SO ATL-DO J50-0100126-0/1/1B
26CHE09 Sesame Oil, Butter, Beans, & Spices
16-JAN-2008 INSANITARY
NO ENGLISH
NUTRIT LBL
UNK
UNK , MY DET-DO 016-1116203-1/3/1
76E--FW Concord Toothbrush
22-JAN-2008 NOT LISTED
LACKS FIRM
REGISTERED
Dabur International Limited
Jebel Ali , AE SWI-DO D52-8900663-2/6/3
54FEA99 Ayuredic Cough Remedy/Dabur Madhuvaani
29-JAN-2008 UNAPPROVED
Dabur International Limited
Jebel Ali , AE SWI-DO D52-8900663-2/6/5
54FEA99 Digestive Tablets/ Dabur Pudin Hara Pearls
29-JAN-2008 UNAPPROVED
Dabur International Limited
Jebel Ali , AE SWI-DO D52-8900663-2/6/6
54ECR99 Digestive Aid/ Dabur Pudin Hara
29-JAN-2008 UNAPPROVED
Dabur International Limited
Jebel Ali , AE SWI-DO D52-8900663-2/6/7
54FEA99 Dabur Hingoli Tablet
29-JAN-2008 UNAPPROVED