November 2020 FDA Recall Anagrelide by Torrent Pharma Inc
D-0166-2021 - Failed Dissolution Specifications
This Class I drug recall was voluntarily initiated by Torrent Pharma Inc on November 25, 2020 for the product Anagrelide. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0166-2021
Failed Dissolution Specifications
11-25-2020
12-09-2020
2496 Bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 USA and Puerto Rico
12-28-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
