Refusal Actions by FDA as Recorded in OASIS for Spain
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Quimica Sintetica, SA
Alcala De Henares, Madrid , ES 28805 NYK-DO 506-0817775-9/1/1
61ECS08 LORATADINE MICRONIZED
13-AUG-2008 DIRECTIONS
Arluy SL Galletas
Logrono La Rioja, ES LOS-DO KE3-5009325-5/1/4
03JFT09 GALLETAS RELLENAS SANDWICH SABOR LIMON (FILLED COOKIES LEMON
14-AUG-2008 UNSAFE COL
Arluy SL Galletas
Logrono La Rioja, ES LOS-DO KE3-5009325-5/1/18
03JFT07 BOMBONETTAS RELLENAS Biscuit with a layer of chocolate and f
14-AUG-2008 LACKS FIRM
USUAL NAME
S/N
Hospitalet De Llobregathospitalet De Llo , E CIN-DO UPS-2092446-8/1/5G
66PBY99 extreme sunscreen lotion
19-AUG-2008 NOT LISTED
Synthon Hispania S.L.
Sant Boi De Llobregatsant Boi De Llobreg , E NOL-DO 112-1794896-0/1/1
66BDY99 837359481298/AMOXETINE 10MG
21-AUG-2008 NOT LISTED
UNAPPROVED
Postquam Cosmetic, S.L.
Valladolidvalladolid , ES 47007 CIN-DO UPS-1945353-7/1/1B
62WAY99 Anti-Acne Gel
21-AUG-2008 NOT LISTED
Quimica Sintetica, SA
Alcala De Henares, Madrid , ES 28805 NYK-DO 506-0817766-8/1/1
60SCS22 FAMOTIDINE
22-AUG-2008 DIRECTIONS
Quimica Sintetica, SA
Alcala De Henares, Madrid , ES 28805 NYK-DO 506-0817766-8/2/1
60SCS22 FAMOTIDINE
22-AUG-2008 DIRECTIONS
Quimica Sintetica, SA
Alcala De Henares, Madrid , ES 28805 NYK-DO 506-0817766-8/3/1
60SCS22 FAMOTIDINE
22-AUG-2008 DIRECTIONS
Quimica Sintetica, SA
Alcala De Henares, Madrid , ES 28805 NYK-DO 506-0817860-9/1/1
60SCS22 FAMOTIDINE
27-AUG-2008 DIRECTIONS