FDA recall D-104-2013

Product

Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR

Reason for recall

Subpotent; 15 month stability

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-10-29

Report date

2013-01-02

Termination date

2014-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Juan, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-104-2013