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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 56-Antibiotics (Human/Animal)

Entry/doc/line/sfx Refusal Date Product
AEK-8626179-5/1/3 12-Jan-2011 56BAA03 3008726214 Jagannail Singh India
AEK-8362122-3/1/1 06-Jan-2011 56BCA03 3008616888 Claudia Bonardi India
XXX-0272047-3/1/4 10-Jan-2011 56BCY03 3007861661 Genfar Colombia
XXX-0270797-5/1/7 03-Jan-2011 56BCY05 3003893445 Bayer, S.A. El Salvador
112-7247944-8/1/1 04-Jan-2011 56BDE03 3005022701 SmithKline Beecham plc United Kingdom
XXX-0270797-5/1/3 03-Jan-2011 56BDY99 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
XXX-0199094-5/1/6 12-Jan-2011 56BDY99 3005331937 Wexford Laboratories Pvt Ltd India
AEK-8582977-4/1/1 04-Jan-2011 56BYY03 3004497364 DSM Sinochem Pharmaceuticals India
112-7378532-2/3/1 04-Jan-2011 56CDE71 3007532922 Relaxpharmaceuticals India
112-7378532-2/3/2 04-Jan-2011 56CDE71 3007532922 Relaxpharmaceuticals India
XXX-0270797-5/1/6 03-Jan-2011 56ECY81 3004543052 THERFAM Guatemala
112-7420525-4/1/1 04-Jan-2011 56GYY04 3007507886 Torrex Chiesi Phar Austria
XXX-0270797-5/1/5 03-Jan-2011 56GYY99 3005203073 Bayer S.A. Guatemala
112-6552967-0/1/1 05-Jan-2011 56ICB10 3006576762 Amherst Laboratories Philippines
T94-0054399-5/1/1 10-Jan-2011 56IYY25 3002943219 Anuh Pharma Limited India
M21-0742836-1/1/1 10-Jan-2011 56JAA22 3007522260 Lyka Bdr International Ltd India
M21-0742763-7/1/1 10-Jan-2011 56JAA22 3007522260 Lyka Bdr International Ltd India
M21-0742762-9/1/1 10-Jan-2011 56JAA22 3007522260 Lyka Bdr International Ltd India
XXX-0270797-5/1/2 03-Jan-2011 56KYY99 3004063802 Laboratorios Pfizer Ltda Brazil
315-6518263-6/1/1 06-Jan-2011 56LKR20 3005301441 Unimax Chemicals Pvt. Ltd. India
T94-0054662-6/1/1 31-Jan-2011 56YCR99 3008723937 Ruidong International Group Co. Ltd. Hong Kong SAR
112-7583347-6/2/1 04-Jan-2011 56YDF99 3007564647 Labormed Pharma Sa Romania
H77-0124176-9/16/1 05-Jan-2011 56YDJ99 3005468685 Mega International Ltd. India