FDA recall D-1862-2019

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 for recall

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

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-09-06

Report date

2019-09-25

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Basking Ridge, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1862-2019