Recalls / Class II
Class IID-085-2013
Product
Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
- Affected lot / code info
- Lot #1097178 exp. 7/31/2013
Why it was recalled
cGMP Deviations; does not meet in process specification requirements
Recalling firm
- Firm
- Lloyd Inc. of Iowa
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 604 W Thomas Ave, N/A, Shenandoah, Iowa 51601-1744
Distribution
- Quantity
- 1,443/100-tablet bottles
- Distribution pattern
- Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Timeline
- Recall initiated
- 2012-07-09
- FDA classified
- 2012-12-03
- Posted by FDA
- 2012-12-12
- Terminated
- 2013-11-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-085-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.