FDA recall D-437-2013

Lloyd Inc. of Iowa · Class II · drug

Product

Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

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-437-2013