Home / Recalls / Boehringer Ingelheim Roxane Inc / D-0011-2016

D-0011-2016 Class III Terminated

Recalled by Boehringer Ingelheim Roxane Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
October 21, 2015
Initiation Date
September 25, 2015
Termination Date
February 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,110 bottles

Product Description

FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.

Reason for Recall

CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 559660P, 559661P, Exp 03/17

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-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-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)