FDA recall D-1084-2014

Mylan Pharmaceuticals Inc. · Class II · drug

Product

Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01

Reason for recall

Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2014-01-14
Report date: 2014-02-19
Termination date: 2015-10-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1084-2014