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FDA (Drug enforcement)Recalled 2013-04-30closedclass ii

King Legacy, a wholly owned subsidiary of Pfizer: Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10)

Is my product affected?

Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

  • Brand LEVOXYL

Check against the official notice below — it lists the full affected range.

What happened

King Legacy, a Pfizer subsidiary, is recalling Levoxyl (levothyroxine sodium) tablets, 100 mcg, distributed nationwide and in Puerto Rico. The recall affects approximately 195,201 bottles in two package sizes: 100-count bottles and 1000-count bottles. The products are being recalled because they were found to be subpotent, meaning they contained less active ingredient than specified at their expiration dates.

The recalled products include multiple lot numbers with expiration dates ranging from April 2013 through November 2013 for the 100-count bottles and April 2013 through August 2013 for the 1000-count bottles. The source document does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Subpotent Drug: The products were below specification for potency at the expiry stability point. Distribution: Nationwide and Puerto Rico Quantity: 195,201 bottles Lot/code info: Lot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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