Status
Terminated
Drug Enforcement D-435-2013
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Classification
Class II
Report Date
May 29, 2013
Termination Date
May 8, 2014
Product Information
- Product description
- Lloyd Thyro-Tab 0.075 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.
- Product quantity
- 9,545,718 tablets
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- 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.
Location & Firm
- Recalling firm
- Lloyd Inc. of Iowa
- Address
-
604 W Thomas Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-435-2013
- Event ID
- 65154
- Recall initiation date
- April 1, 2013
- Center classification date
- May 21, 2013
- Code info
- Lot #: HC04712, Exp. Mar-13; HD08112, Exp. Apr-13; HE08112, HD11112, Exp May-13.
- More code info
- —