D-1862-2019 Class II Terminated

Recalled by Torrent Pharma Inc. — Basking Ridge, NJ

Recall Details

Product Type
Drugs
Report Date
September 25, 2019
Initiation Date
September 6, 2019
Termination Date
November 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2472 bottles

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #: BFE2E003, Exp 08/31/2020