FDA recall D-085-2013

Product

Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Reason for recall

cGMP Deviations; does not meet in process specification requirements

Distribution

Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

Key facts

Status

Terminated

Initiation date

2012-07-09

Report date

2012-12-12

Termination date

2013-11-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shenandoah, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-085-2013