Oral solution of levothyroxine sodium recalled due to possible subpotent doses
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A voluntary recall has been issued for an oral solution of levothyroxine sodium due to possible subpotency among some of the manufactured products, according to a company press release.
IBSA Pharma announced a voluntary recall for 27 lots of its levothyroxine oral solution (Tirosint-SOL) on January 31. The recall affects only the levothyroxine oral solution and does not apply to levothyroxine sodium capsules.
The voluntary recall affects levothyroxine sodium with the following lot numbers: 220409, 220956, 220856, 220552, 221055, 220553, 221056, 220407, 220960, 220556, 221058, 220853, 220411, 220854, 220413, 220964, 220414, 220852, 220970, 220855, 220415, 221052, 220959, 220416, 221053, 220418 and 220560.
Levothyroxine sodium has been approved by the FDA for use as a replacement therapy for adults with primary, secondary or tertiary congenital or acquired hypothyroidism, as well as for pituitary thyrotropin suppression as an adjunct to surgery and radioactive iodine therapy in the management of thyrotropin-dependent . According to the recall announcement, adults with hypothyroidism using subpotent levothyroxine sodium have a risk for exhibiting signs and symptoms of hypothyroidism, including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and unexplained weight gain or difficulty losing weight. IBSA Pharma has not received any reports of adverse events related to the recall, according to the press release.
IBSA Pharma is notifying its wholesalers, retailers and health care providers to stop distributing the affected lot numbers. Anyone who is taking levothyroxine sodium oral solution should continue taking it until they contact their provider for guidance or a receive replacement prescription.
Any patients and providers with questions about the recall can contact IBSA Pharma at 1-800-587-3515 Monday through Friday from 9 a.m. to 7 p.m. Eastern Standard Time, or at medinfo@ibsapharma.com. Adverse events or quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by regular mail or fax using the form at www.fda.gov/MedWatch/getforms.htm and mailing it to the address listed or submitting it by fax to 1-800-FDA-0178
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