D-0098-2018 Class II Terminated

Recalled by Mayne Pharma Inc — Greenville, NC

FDA drug recall D-0098-2018 was initiated by Mayne Pharma Inc on Nov 9, 2017 and is designated Class II. Reason for recall: Failed Dissolution Specifications. The recall status is terminated (terminated May 11, 2020). Affected quantity: 11,364 bottles.

Recall Details

Product Type
Drugs
Report Date
Dec 6, 2017
Initiation Date
Nov 9, 2017
Termination Date
May 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,364 bottles

Product Description

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 Pattern

Nationwide within USA

Code Information

Lot: #:16F649, Exp: May 2018

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0098-2018
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0098-2018. Report a data issue: hello@regdatalab.com.