Recalls / Class II
Class IID-446-2013
Product
Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01
- Affected lot / code info
- Lot #: 1095208, Exp Apr-13; 1097177, Exp Jul-13; 1098537 , Exp Aug-13.
Why it was recalled
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Recalling firm
- Firm
- Lloyd Inc. of Iowa
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 604 W Thomas Ave, N/A, Shenandoah, Iowa 51601-1744
Distribution
- Quantity
- 40,311 Bottles
- 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.
Timeline
- Recall initiated
- 2013-04-01
- FDA classified
- 2013-05-21
- Posted by FDA
- 2013-05-29
- Terminated
- 2014-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-446-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.