September 2019 FDA Recall Anagrelide by Torrent Pharma Inc.
D-1862-2019 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Torrent Pharma Inc. on September 6, 2019 for the product Anagrelide. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1862-2019
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
09-06-2019
09-25-2019
2472 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.
Torrent Pharma 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
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico
11-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
