Home / Recalls / Boehringer Ingelheim Roxane Inc / D-1486-2014

D-1486-2014 Class III Terminated

Recalled by Boehringer Ingelheim Roxane Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
August 6, 2014
Initiation Date
July 28, 2014
Termination Date
May 29, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,149 Bottles

Product Description

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.

Reason for Recall

Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

Distribution Pattern

U.S. Nationwide

Code Information

Lot #: 360241A, Expiry: 05/2015.

Other recalls by Boehringer Ingelheim Roxane Inc

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  • 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-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)