IBSA Pharma Inc. has issued a voluntary recall of 27 lots of a drug used to treat hypothyroidism.
Tirosint-sol (levothyroxine sodium) is being recalled because the lots may be less potent. Some of the lots tested showed a slight decrease in the drug’s potency, the company reported.
This recall does not apply to Tirosint (levothyroxine sodium) capsules.
According to the company, “patients being treated for hypothyroidism (underactive thyroid), who receive subpotent Tirosint-sol, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.”
The drug is used to treat hypothyroidism and suppress thyroid-stimulating hormones.
Click here to see the product description, NDC numbers, lot numbers, and expiration dates of the affected Tirosint-sol lots.
IBSA Pharma Inc. is telling patients who are taking Tirosint-sol to continue using the medication until contacting their healthcare provider for further guidance and/or a replacement prescription.
Consumers and healthcare providers with questions about the recall can contact IBSA Pharma Inc. at 1-800-587-3513 Monday through Friday between 9 a.m. and 7 p.m., EST, or by e-mail at medinfo@ibsapharma.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking the drug.
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