Status
Terminated
Drug Enforcement D-450-2013
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
- Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01
- Product quantity
- 32,345 Bottles
- 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-450-2013
- Event ID
- 65154
- Recall initiation date
- April 1, 2013
- Center classification date
- May 21, 2013
- Code info
- Lot #r: 1095922, Exp May-13; 1097735, Exp Jul-13; 1099892, Exp Oct-13.
- More code info
- —