Boehringer Ingelheim Roxane Inc

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0011-2016Class IIIFUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories,September 25, 2015
D-0012-2016Class IIIFUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories,September 25, 2015
D-1279-2015Class IICOMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuatioJuly 24, 2015
D-1085-2015Class IIAcarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, RApril 2, 2015
D-1486-2014Class IIIOXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer IngelheiJuly 28, 2014
D-1427-2014Class IICalcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 4May 1, 2014
D-1314-2014Class IIIMercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, OApril 4, 2014
D-1313-2014Class IIIAzathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, OhApril 4, 2014
D-1230-2014Class IIISpiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use March 27, 2014
D-1057-2013Class IIISPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 cAugust 30, 2013
D-882-2013Class IIIPrednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, tenJune 14, 2013
D-002-2014Class IIOxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane LabApril 3, 2013
D-343-2014Class IIIOxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged iMarch 18, 2013
D-126-2013Class IIIPerindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane LabDecember 12, 2012
D-067-2013Class IIPradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by BoehringerNovember 5, 2012