D-434-2013 Class II Terminated
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
- 19,787 Bottles
Product Description
Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01
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 #: 1098752, Exp. Mar-13; 1099890, Exp Apr-13.