Recall: D-1862-2019

Class II - Potentially Harmful

Class IIClassification

2019-09-06Initiated

TerminatedStatus

Torrent Pharma Inc.Firm

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.

Reason

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

Distribution

Nationwide in the USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.