Safety Alerts & Recalls
What does this mean?
These recalls for Levoxyl tablets from King Pharmaceuticals/Pfizer were issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. No other levothyroxine (Levo-T, Levothroid, Synthroid, and others) products were involved in this recall.
If you take Levoxyl, continue to take your medication as prescribed by your doctor. You do not need to return or discard your medication.
Due to these recalls, Levoxyl is currently not available in pharmacies. A new supply of Levoxyl may not be available until 2014. You should contact your healthcare provider to discuss alternate treatment options.
As with all thyroid hormone replacement medicine, please watch for symptoms of thyroid hormone levels that are too high or too low. If you experience any concerning symptoms or if you have questions about your treatment, please follow up with your healthcare provider.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Recall of Levoxyl Produces Medication Shortage
King Pharmaceuticals, a subsidiary of Pfizer, has recently issued two recalls of Levoxyl (levothyroxine sodium), which is used to treat hypothyroidism (low thyroid hormone levels) and certain types of goiter.
The first recall was issued after learning of complaints from pharmacists and patients of an unusual odor coming from the Levoxyl bottles. It was determined that the odor was caused by an oxygen-absorbing canister added to the pharmacy bottles to improve the stability of the product. Pfizer conducted a health assessment of the situation and determined that this odor was not likely to cause any adverse health issues. However, out of caution, the company decided to voluntarily recall the product to the pharmacy level.
The second recall was issued because some tablets didn't meet potency standards and may have lower levels of the thyroid hormone medicine. Pfizer said the use of less potent Levoxyl tablets carries a rare risk of serious adverse events because it may affect the management of hypothyroidism. Only three batches of Levoxyl tested for stability produced results outside of the quality specifications, but as a conservative measure the company decided to recall all batches at the pharmacy level.
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