Home / Recalls / King Legacy, a wholly owned subsidiary of Pfizer / D-428-2013

D-428-2013 Class II Terminated

Recalled by King Legacy, a wholly owned subsidiary of Pfizer — Bristol, TN

Recall Details

Product Type
Drugs
Report Date
May 29, 2013
Initiation Date
April 30, 2013
Termination Date
June 30, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
77,272 bottles

Product Description

Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Reason for Recall

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13

Other recalls by King Legacy, a wholly owned subsidiary of Pfizer

  • D-427-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count b (April 30, 2013)
  • D-426-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count b (April 30, 2013)
  • D-421-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bo (April 30, 2013)
  • D-431-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count b (April 30, 2013)
  • D-424-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bo (April 30, 2013)
  • D-425-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count b (April 30, 2013)
  • D-422-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bo (April 30, 2013)
  • D-430-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count b (April 30, 2013)
  • D-423-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bo (April 30, 2013)
  • D-429-2013 Class II — Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count b (April 30, 2013)