Refusal Actions by FDA as Recorded in OASIS


   Country of Origin                     Entry #   DOC  Line Suffix
   Manufacture Name
   City / Country or region                                 District
   Product Code        Product Description
                          Date                              Reason
China EB5-0041072-6 4 1 Hangzhou FST Chemical Co., Ltd. Hangzhou , CN 1234 NYK-DO 60CCS22 SYNEPHRINE 24-SEP-2008 NOT LISTED DIRECTIONS Singapore 112-4272209-1 1 1 Pharma 2000 Pte Ltd Singapore , SG 408938 NOL-DO 60IDB01 935197826268 Uralyt Urato (CITRATE POTASSIUM) 19-SEP-2008 UNAPPROVED Canada 112-4312846-2 1 1 Wyeth Consumer Hea Mississauga ON, CA L4Z3M6 NOL-DO 60LAB05 866967026960 /ASPIRIN 19-SEP-2008 UNAPPROVED France K74-0148185-1 8 1 B Bristol Myers Squibb Agen , FR 47000 CHI-DO 60LAL01 Efferalgan Paracetamol - Pediatrique Bouchon 22-SEP-2008 NOT LISTED DIRECTIONS NO ENGLISH UNAPPROVED France K74-0148185-1 8 1 C Bristol Myers Squibb Agen , FR 47000 CHI-DO 60LAL01 Efferalgan Paracetamol - 500 mg 22-SEP-2008 NOT LISTED DIRECTIONS NO ENGLISH UNAPPROVED Canada AEK-9533847-7 1 6 Rose Janzen Tillsonburg ON, CA N4G3A2 CIN-DO 60LCA05 ASA 81MG 02-SEP-2008 UNAPPROVED Canada 112-4116154-9 1 1 Glaxosmithkline Biologicals Laval QUEBEC, CA H7V3S8 NOL-DO 60LDA89 864280112230 APO-SUMATRIPTAN 100 MG 19-SEP-2008 UNAPPROVED Norway DO7-8203920-3 1 1 Glaxosmithkline A.S. Bergen , NO 5013 NYK-DO 60LDQ99 SUMATRIPTAN(FOR PERSONAL) 29-SEP-2008 NOT LISTED UNAPPROVED Germany 112-3884338-0 1 1 Bayer Ag Leverkusen , DE 51304 NOL-DO 60RCE99 865809822461 clobenzorex HCl 03-SEP-2008 UNAPPROVED United States UPS-2200580-3 1 1 Lorenzo Caporal Golpe Mexicomexico , MX 95700 CIN-DO 60SIN99 UNKNOWN MEDICATION , NO LABELING, RETURNING FOR DESTRUCTION 19-SEP-2008 UNAPPROVED India AEK-9564217-5 1 1 Micro Labs Limited Chennai , IN CIN-DO 60WCA16 MEDICATION/ MEBENDAZOLE 500MG 24-SEP-2008 UNAPPROVED