D-438-2013 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
- 21,019,909 tablets
Product Description
Lloyd Thyro-Tab 0.100 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 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 #: HA27211, HB27211, HC27211, HD27211, Exp Apr-13; HB31411, Exp May-13; HD35511, HA35511, HB35511, HC35511, Exp Jul-13; HA06212, HB06212, Exp Sep-13.