FDA recall D-450-2013

Lloyd Inc. of Iowa · Class II · drug

Product

Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01

Reason for recall

cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

Distribution

The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2013-04-01
Report date: 2013-05-29
Termination date: 2014-05-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Shenandoah, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-450-2013