Anagrelide Capsule
FDA Recall NDC 13668-462
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Anagrelide (NDC 13668-462). A significant event, classified as Class I, was initiated on Nov 25, 2020 by Torrent Pharmaceuticals Limited. The reported reason for this action was: "Failed Dissolution Specifications"
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 I Terminated
Failed Dissolution Specifications
Nov 25, 2020
Dec 09, 2020
2496 Bottles
Recall Profile & Regulatory Data
Event ID
86878
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Torrent Pharma Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Dec 28, 2022
Product Description
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
Batch or Lot Expiration Information
Batch# Batch BFD1G001, exp 12/2021
Affected Packages Involved in this Recall
13668-453-30Product
13668-453-01Product
13668-462-30Product
13668-462-01Product
September 2019 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Sep 06, 2019
Sep 25, 2019
2472 bottles
Recall Profile & Regulatory Data
Event ID
83733
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Torrent Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Nov 03, 2020
Product Description
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
Batch or Lot Expiration Information
Lot# : BFE2E003, Exp 08/31/2020
Affected Packages Involved in this Recall
13668-453-30Product
13668-453-01Product
13668-462-30Product
13668-462-01Product
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.
