Home / Recalls / Boehringer Ingelheim Roxane Inc / D-002-2014

D-002-2014 Class II Terminated

Recalled by Boehringer Ingelheim Roxane Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
November 27, 2013
Initiation Date
April 3, 2013
Termination Date
February 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,267 bottles

Product Description

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59

Reason for Recall

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

Distribution Pattern

Nationwide

Code Information

Lot # 161304B, Exp. OCT 2013

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)
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  • 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)