• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 62511
Product Type Drugs
Status Ongoing
Recalling Firm Lloyd Inc. of Iowa
City Shenandoah
State IA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-09
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #1097178 exp. 7/31/2013 Class II cGMP Deviations; does not meet in process specification requirements 1,443/100-tablet bottles D-085-2013
Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HE35311 Class II cGMP Deviations; does not meet in process specification requirements 1,902,957 tablets D-084-2013
Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1095212 exp. 4/30/2013; and #1088877, exp. 11/30/2012 Class II cGMP Deviations; does not meet in process specification requirements 36,978/100-tablet bottles D-083-2013
Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HA27911 and #HA12511 Class II cGMP Deviations; does not meet in process specification requirements 3,774,541 tablets D-082-2013
Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1095210, exp. 4/30/2013 Class II cGMP Deviations; does not meet in process specification requirements 19,162/100-tablet bottles D-081-2013
Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HB27811 Class II cGMP Deviations; does not meet in process specification requirements 1,924,174 tablets D-080-2013
Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1096371, exp. 5/312013; and #1092299, exp. 1/31/2013 Class II cGMP Deviations; does not meet in process specification requirements 37,827/100-tablet bottles D-079-2013
Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HC31411 and #HE18711 Class II cGMP Deviations; does not meet in process specification requirements 3,813,645 tablets D-078-2013
Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012 Class II cGMP Deviations; does not meet in process specification requirements 31,252/100-tablet bottles D-077-2013
Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HA31411 and #HE17811 Class II cGMP Deviations; does not meet in process specification requirements 3,826,269 tablets D-076-2013
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1097830 exp. 1/31/2013 Class II cGMP Deviations; does not meet in process specification requirements 13,692/100-tablet bottles D-075-2013
Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HB01212 Class II cGMP Deviations; does not meet in process specification requirements 1,923,887 tablets D-074-2013
-
-