Recalls / Class II

Class IID-0098-2018

Product

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

Affected lot / code info

Lot: #:16F649, Exp: May 2018

Why it was recalled

Failed Dissolution Specifications.

Recalling firm

Firm

Mayne Pharma Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1240 Sugg Pkwy, N/A, Greenville, North Carolina 27834-9006

Distribution

Quantity

11,364 bottles

Distribution pattern

Nationwide within USA

Timeline

Recall initiated

2017-11-09

FDA classified

2017-11-29

Posted by FDA

2017-12-06

Terminated

2020-05-11

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0098-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.