FDA recall D-0098-2018

Mayne Pharma Inc · Class II · drug

Product

Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01

Reason for recall

Failed Dissolution Specifications.

Distribution

Nationwide within USA

Key facts

Status
Terminated
Initiation date
2017-11-09
Report date
2017-12-06
Termination date
2020-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greenville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0098-2018