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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
554-6579599-9/7/1 21-Mar-2012 60CCS02 3008838490 Basf Pharmachemikalien Gmbh & Co.Kg Germany
 
300-8940746-2/1/1 08-Mar-2012 60D99 3006765340 Acetar Bio-Tech Inc. China
 
112-6220234-9/1/2 30-Mar-2012 60LAA01 3005250467 Idi Farmaceutici Italy
 
M50-0201531-6/4/1 29-Mar-2012 60LAJ99 3003986222 Pax-All Manufacturing Inc Canada
 
M50-0200080-5/4/1 29-Mar-2012 60LAJ99 3003986222 Pax-All Manufacturing Inc Canada
 
438-0810973-0/16/1 08-Mar-2012 60LBJ07 3003138396 Laboratorios Roldan S.A. Dominican Republic
 
438-0810973-0/16/2 23-Mar-2012 60LBL07 3003138396 Laboratorios Roldan S.A. Dominican Republic
 
K80-1005335-4/2/2 02-Mar-2012 60LBL99 3005686897 Yunnan Baiyao Group Co Ltd. China
 
AEK-8396917-6/2/1 29-Mar-2012 60LCA01 3009415429 Selim Sheikh Bangladesh
 
112-6516659-0/2/1 30-Mar-2012 60LCB05 1000123383 Dollar Tree Distribution, Inc. United States
 
112-5424399-6/1/2 21-Mar-2012 60LDA13 3009286386 The Medrass Pharmaceutical India
 
112-6415795-4/1/1 30-Mar-2012 60LDB17 3004535474 Merck Sharp & Dohme Mexico
 
677-0324526-5/2/1 28-Mar-2012 60LDL01 2935 Dong-A Pharmaceutical Co., Ltd. Korea, Republic Of (South)
 
XXX-0249017-6/1/1 05-Mar-2012 60LDY05 3005203073 Bayer S.A. Guatemala
 
XXX-0249017-6/1/2 05-Mar-2012 60LDY05 3005203073 Bayer S.A. Guatemala
 
336-6248476-9/1/1 07-Mar-2012 60MDY04 3003675936 Alza Corporation United States
 
336-6248476-9/1/2 07-Mar-2012 60MDY04 3003675936 Alza Corporation United States
 
336-6248476-9/1/3 07-Mar-2012 60MDY04 3003675936 Alza Corporation United States
 
336-6248476-9/1/4 07-Mar-2012 60MDY04 3003675936 Alza Corporation United States
 
336-6248476-9/1/5 07-Mar-2012 60MDY04 3003675936 Alza Corporation United States
 
112-5813340-9/1/1 14-Mar-2012 60QCK07 3003589503 AstraZeneca UK Ltd United Kingdom
 
112-5813340-9/2/1 14-Mar-2012 60QCK79 3005886810 Astrazeneca Pharmaceuticals Sa Belgium
 
AEK-0085207-5/1/3 23-Mar-2012 60QDY69 3009401588 Pasupathy India
 
J89-0116748-8/5/1 22-Mar-2012 60SBR99 3004046278 Popat Raja & Sons India
 
112-5424399-6/1/3 21-Mar-2012 60SDA20 3007517883 Zydus Healthcare India
 
523-0962790-0/1/1 30-Mar-2012 60WQS01 3009283902 Changzhou Yabang-Qh Pharmachem China
 
AEK-8396917-6/1/3 29-Mar-2012 60XCA17 3009415429 Selim Sheikh Bangladesh
 
UPS-5471904-8/1/3 23-Mar-2012 60XCY02 3009423026 Flor Maria Sabogal Colombia
 
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