Refusal Actions by FDA as Recorded in OASIS for Egypt
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Glaxosmith Kline
Cairo , EG NOL-DO 112-0789750-8/1/1
62GDA49 957113347025 VALTREX 500 MG
02-JUN-2008 UNAPPROVED
British Egyptian Company
Alexandria , EG NYK-DO 551-7303962-4/1/1
20AGD14 IQF FROZEN STRAWBERRIES
11-JUN-2008 PESTICIDES
Golden Sun Intl
Cairo , EG NYK-DO U61-0086082-7/2/1
25YCT99 PICKLED ONIONS
12-JUN-2008 NEEDS FCE
Egyptian Canning Company - Americana
6th October City EG-GZ, EG N/A SEA-DO AVB-0602216-0/1/1
21GET09 SLICED RIPE OLIVES
18-JUN-2008 FALSE
PESTICIDES
Egyptian Canning Company - Americana
6th October City EG-GZ, EG N/A SEA-DO AVB-0602216-0/1/2
21GET09 SLICED RIPE OLIVES
18-JUN-2008 PESTICIDES
Aventis Pharma
Cairocairo , EG 103 NOL-DO 112-2811074-1/1/1
62LAA40 969358967587/FLAGYL 500MG
20-JUN-2008 UNAPPROVED
Pfizer Egypt
Caire , EG NOL-DO 112-2811074-1/1/2
61WAA45 969358967587/DIFLUCAN 150MG
20-JUN-2008 UNAPPROVED
Golden Sun Intl
Cairo , EG NYK-DO U61-0086108-0/4/1
12CEP17 FETA CHEESE
23-JUN-2008 LEAK/SWELL
Sanofi Aventis
Cairo , EG NOL-DO 112-0968646-1/1/1
62LCB50 958450682723.FLAGYL 250MG
26-JUN-2008 UNAPPROVED