Boehringer Ingelheim Roxane Inc
Boehringer Ingelheim Roxane Inc appears in FDA public data with 15 recalls, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0012-2016, Class III) was initiated on September 25, 2015.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0012-2016 | Class III | FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, | September 25, 2015 |
| D-0011-2016 | Class III | FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, | September 25, 2015 |
| D-1279-2015 | Class II | COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuatio | July 24, 2015 |
| D-1085-2015 | Class II | Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, R | April 2, 2015 |
| D-1486-2014 | Class III | OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelhei | July 28, 2014 |
| D-1427-2014 | Class II | Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 4 | May 1, 2014 |
| D-1313-2014 | Class III | Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Oh | April 4, 2014 |
| D-1314-2014 | Class III | Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, O | April 4, 2014 |
| D-1230-2014 | Class III | Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use | March 27, 2014 |
| D-1057-2013 | Class III | SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 c | August 30, 2013 |
| D-882-2013 | Class III | Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten | June 14, 2013 |
| D-002-2014 | Class II | Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Lab | April 3, 2013 |
| D-343-2014 | Class III | Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged i | March 18, 2013 |
| D-126-2013 | Class III | Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Lab | December 12, 2012 |
| D-067-2013 | Class II | Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer | November 5, 2012 |