May 2014 FDA Recall Calcitriol by Boehringer Ingelheim Roxane Inc
D-1427-2014 - Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Roxane Inc on May 1, 2014 for the product Calcitriol. The FDA reported the reason for recall as failed impurity/degradation specification; out of specification for trans-calcitriol degradant at the 9 month stability time point. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1427-2014
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
05-01-2014
07-16-2014
5364 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-01-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Batch or Lot Expiration Information
Lot# 360122A, EXP Date: MAY 2015
