Calcitriol Solution
FDA Recall NDC 0054-3120
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Calcitriol (NDC 0054-3120). A significant event, classified as Class II, was initiated on May 01, 2014 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
May 2014 Class II Recall: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Recall Number
Class II Terminated
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
May 01, 2014
Jul 16, 2014
5364 bottles
Recall Profile & Regulatory Data
Event ID
68389
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 01, 2015
Product Description
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
Affected Packages Involved in this Recall
0054-3120-41Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
