Calcitriol Capsule
FDA Recall NDC 63304-239
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 63304-239). A significant event, classified as Class III, was initiated on Jun 15, 2018 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Subpotency: lower than expected potency result was obtained at the 18 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
Class III Terminated
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Jun 15, 2018
Sep 05, 2018
7864 bottles
Recall Profile & Regulatory Data
Event ID
80326
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Validus Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. nationwide
Termination Date
Jan 22, 2021
Product Description
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Batch or Lot Expiration Information
Lot# RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019
Affected Packages Involved in this Recall
63304-239-30Product
63304-239-01Product
63304-240-01Product
63304-241-59Product
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.
