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Levoxyl® Voluntarily Recalled

Branded levothyroxine containing medication Levoxyl® is being voluntarily recalled by King Pharmaceuticals LLC, a subsidiary of Pfizer Inc.  This voluntary recall is due to an uncharacteristic odor from the Levoxyl® bottles.  The packaging defect has been tracked to the preservative canister added to the stock bottles which is supposed to absorb oxygen to preserve the shelf-life of the medication.

Pfizer has conducted a careful risk assessment and has determined that there is little to no risk of any adverse health events due to this packaging defect.  Regardless, Pfizer, King, and the FDA have worked together and decided to voluntarily recall at the pharmacy level, all Levoxyl® strengths.

SUMMARY: Voluntary Recall at the Pharmacy Level of Levoxyl®
What Should I Do? Continue taking your medication as allowed by the FDA and contact your physician about alternative therapy as it may not be available until 2014.

Levoxyl LabelPfizer and the FDA state that it is not necessary for patients to return or discard their Levoxyl® medication, and to continue its use, however it is important to contact your health care provider and/or pharmacist as ALL STRENGTHS of Levoxyl® will undergo a temporary OUT OF STOCK status and may not return until 2014.

The dosing of this medication has a narrow therapeutic index, which means that very careful dosage titration is needed to avoid adverse drug events.  Levothyroxine is available in brand name Synthroid® and a number of generic Levothyroxine forms, however careful discussion may be necessary with your health care provider as this particular medication may have different absorptions across different manufacturers for different individuals.

By:

Jeremy KW Spiewak, Pharmacy Intern, CPhT, MA RPhT, BA Chemistry, Doctor of Pharmacy Candidate at Massachusetts College of Pharmacy and Health Sciences

Further Reading:

Levoxyl Package Insert King Pharmaceuticals Inc.

Pfizer for professionals- Important Information for Patients: Voluntary Recall of Levoxyl

Revised 04/05/2013