Home / Recalls / Boehringer Ingelheim Roxane Inc / D-1230-2014

D-1230-2014 Class III Terminated

Recalled by Boehringer Ingelheim Roxane Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
April 16, 2014
Initiation Date
March 27, 2014
Termination Date
January 26, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,276,710 Blister Cards

Product Description

Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.

Reason for Recall

Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014

Other recalls by Boehringer Ingelheim Roxane Inc

  • D-0011-2016 Class III — FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim (September 25, 2015)
  • D-0012-2016 Class III — FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim (September 25, 2015)
  • D-1279-2015 Class II — COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/ (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 (April 2, 2015)
  • D-1486-2014 Class III — OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. (July 28, 2014)
  • D-1427-2014 Class II — Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, In (May 1, 2014)
  • D-1314-2014 Class III — Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratorie (April 4, 2014)
  • D-1313-2014 Class III — Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories (April 4, 2014)
  • D-1057-2013 Class III — SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per do (August 30, 2013)
  • D-882-2013 Class III — Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets p (June 14, 2013)