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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, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10),

Is my product affected?

Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), 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, 75 mcg, distributed nationwide and in Puerto Rico. The recall affects 194,142 bottles in two package sizes: 100-count bottles (NDC 60793-852-01) and 1000-count bottles (NDC 60793-852-10). 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 recall includes multiple lot numbers with expiration dates ranging from April 2013 through September 2013. Consumers who have bottles matching any of the affected lot numbers (for 100-count: 64197, 64339, 65061, 65236, 65917, 66122, or 66427; for 1000-count: 64340, 64933, 65062, 65237, 65238, or 66121) should check their medication. The source document does not specify what action affected consumers should take.

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: 194,142 bottles Lot/code info: Lot # a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, 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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