D-0166-2021 Class I Terminated

Recalled by Torrent Pharma Inc — Levittown, PA

FDA drug recall D-0166-2021 was initiated by Torrent Pharma Inc on November 25, 2020 and is designated Class I. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated December 28, 2022). Affected quantity: 2496 Bottles.

Recall Details

Product Type
Drugs
Report Date
December 9, 2020
Initiation Date
November 25, 2020
Termination Date
December 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2496 Bottles

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

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Batch BFD1G001, exp 12/2021