FDA recall D-1393-2012

Product

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.

Reason for recall

Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.

Distribution

Nationwide and PR.

Key facts

Status

Terminated

Initiation date

2012-02-03

Report date

2012-07-04

Termination date

2013-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shenandoah, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1393-2012