D-433-2013 Class II Terminated
FDA drug recall D-433-2013 was initiated by Lloyd Inc. of Iowa on April 1, 2013 and is designated Class II. 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. The recall status is terminated (terminated May 8, 2014). Affected quantity: 7,681,277 tablets.
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
- 7,681,277 tablets
Product Description
Lloyd Thyro-Tab 0.050 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 #: HB04712, Exp. Mar-13, HB08112, HC08112, Exp Apr-13, and HC11112 May-13.