FDAClass IISeptember 25, 2019

Anagrelide Capsules recall: Impurity Out of Spec

Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC…

Why was Anagrelide Capsules recalled?

Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: BFE2E003, Exp 08/31/2020

Product
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC…
Recalling firm
Torrent Pharma Inc.
Quantity
2472 bottles
Distribution
Nationwide in the USA and Puerto Rico
Recall date
September 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls