Home / Recalls / Boehringer Ingelheim Roxane Inc / D-1427-2014

D-1427-2014 Class II Terminated

Recalled by Boehringer Ingelheim Roxane Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
July 16, 2014
Initiation Date
May 1, 2014
Termination Date
April 1, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5364 bottles

Product Description

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

Reason for Recall

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

Distribution Pattern

Nationwide

Code Information

Lot # 360122A, EXP Date: MAY 2015

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  • 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)
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