Paricalcitol Capsule, Liquid Filled
FDA Recall NDC 55111-663
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Paricalcitol (NDC 55111-663). A significant event, classified as Class III, was initiated on Nov 04, 2015 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules."
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
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Nov 04, 2015
Feb 24, 2016
9,155 bottles
Recall Profile & Regulatory Data
Event ID
72648
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 22, 2017
Product Description
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
Batch or Lot Expiration Information
Lot# s: C404795, C404796, C404797, Exp 05/2016; C406272, C406273, C406274, C406518, Exp 07/2016; C409586, C409587, Exp 11/2016; C409588, Exp 12/2016; C501835, C501836 , C501837, Exp 02/2017; C503797, C503798, Exp 05/2017; C505009, Exp 06/2017; C505568, C505569, Exp 07/2017
Affected Packages Involved in this Recall
55111-663-30Product
55111-663-01Product
55111-663-05Product
55111-663-79Product
55111-663-81Product
55111-664-30Product
55111-664-01Product
55111-664-05Product
55111-664-79Product
55111-664-81Product
55111-665-30Product
55111-665-01Product
55111-665-05Product
55111-665-79Product
55111-665-81Product
Class III Terminated
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Nov 04, 2015
Feb 24, 2016
4383 bottles
Recall Profile & Regulatory Data
Event ID
72648
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 22, 2017
Product Description
Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30
Batch or Lot Expiration Information
Lot# s: C404653, C404654, C404655, Exp 05/2016; C505010, Exp 06/2017
Affected Packages Involved in this Recall
55111-663-30Product
55111-663-01Product
55111-663-05Product
55111-663-79Product
55111-663-81Product
55111-664-30Product
55111-664-01Product
55111-664-05Product
55111-664-79Product
55111-664-81Product
55111-665-30Product
55111-665-01Product
55111-665-05Product
55111-665-79Product
55111-665-81Product
Class III Terminated
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Nov 04, 2015
Feb 24, 2016
11,123 bottles
Recall Profile & Regulatory Data
Event ID
72648
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 22, 2017
Product Description
Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30
Batch or Lot Expiration Information
Lot# s: C404440, Exp 04/2016; C404946, Exp 05/2016; C505704, Exp 07/2017
Affected Packages Involved in this Recall
55111-663-30Product
55111-663-01Product
55111-663-05Product
55111-663-79Product
55111-663-81Product
55111-664-30Product
55111-664-01Product
55111-664-05Product
55111-664-79Product
55111-664-81Product
55111-665-30Product
55111-665-01Product
55111-665-05Product
55111-665-79Product
55111-665-81Product
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.
