D-446-2013 Class II Terminated

Recalled by Lloyd Inc. of Iowa — Shenandoah, IA

Recall Details

Product Type
Drugs
Report Date
May 29, 2013
Initiation Date
April 1, 2013
Termination Date
May 8, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40,311 Bottles

Product Description

Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01

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 Pattern

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.

Code Information

Lot #: 1095208, Exp Apr-13; 1097177, Exp Jul-13; 1098537 , Exp Aug-13.