Home / Recalls / Boehringer Ingelheim Roxane Inc / D-1085-2015

D-1085-2015 Class II

Recalled by Boehringer Ingelheim Roxane Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
June 3, 2015
Initiation Date
April 2, 2015
Termination Date
February 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 575 Blister Packs, b) 12,802 Bottles

Product Description

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

Reason for Recall

Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016

Other recalls by Boehringer Ingelheim Roxane Inc

  • D-0012-2016 Class III — FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim (September 25, 2015)
  • D-0011-2016 Class III — FUROSEMIDE Tablets USP, 20 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-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-1313-2014 Class III — Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories (April 4, 2014)
  • D-1314-2014 Class III — Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratorie (April 4, 2014)
  • D-1230-2014 Class III — Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriv (March 27, 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)