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Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma I...

FDA Recall #D-0166-2021 — Class I — November 25, 2020

Recall #D-0166-2021 Date: November 25, 2020 Classification: Class I Status: Terminated

Product Description

Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01

Reason for Recall

Failed Dissolution Specifications

Recalling Firm

Torrent Pharma Inc — Levittown, PA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

2496 Bottles

Distribution

Nationwide USA and Puerto Rico

Code Information

Batch BFD1G001, exp 12/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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