IBSA Pharma Inc. has issued a voluntary recall of 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution.
The consumer-level recall was initiated after the company analysis revealed the possible subpotency of these products. The analysis showed that some lots decreased below 95.0% of their labelled amount in levothyroxine sodium (T4).
Risk Statement
If patients under treatment for hypothyroidism (underactive thyroid) receive the sub-potent TIROSINT®-SOL, they may experience symptoms such as:
- Fatigue
- Dry skin
- Constipation
- Cold sensitivity
- Slow heart rate
- Puffy eyes
- Hair loss
- Depression
- Swelling of the thyroid glands
- Weight gain
- Difficulty losing weight
Patients who are overdosed or underdosed with TIROSINT® SOL may experience some negative effects, such as growth and development issues, bone metabolism, cardiovascular function, reproductive function, emotional state, gastrointestinal function, cognitive function, and glucose and lipid metabolism.
Patients, especially pregnant women, elderly persons, and infants, should contact their physicians immediately if they experience any negative symptoms associated with using these drugs. IBSA Pharma Inc. has not received any reports of adverse reactions that may be related to the use of these drugs.
Indications
TIROSINT®-SOL is indicated for the treatment of:
- Hypothyroidism: Used as replacement primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
- Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: In the management of thyrotropin-dependency and well-differentiated thyroid cancer as an adjunct to surgery and radioiodine therapy.
TIROSINT®-SOL oral solution comes in a clear, colorless to slightly yellow solution in 1 mL of a white, non-transparent, unit-dose ampule. The box and the pouch contain the dosage strength and come with a distinct color.
IBSA Pharma Inc. notifies wholesalers, retailers and healthcare providers about the recall and is arranging for the return of the affected products.
The parties should stop any further distribution of the product and notify their customers about the recall. Patients taking TIROSINT®-SOL should contact their healthcare providers to find an alternative to the medication.
Consumers and healthcare providers with questions concerning this recall can contact IBSA Pharma Inc. by phone number at 1-800-587-3513 Monday to Friday between 9:00 am to 7:00 pm (EST) or send an email to [email protected].
Consumers who experience any side effects after using this medication should talk to their healthcare provider.
Wholesalers and retailers with questions regarding this recall can contact BSA Pharma Inc. by phone number 855-224-0231 Monday to Friday between 8:00 am to 5:00 pm (CST) or send an email to [email protected].
Adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program through the following channels:
Complete and submit the report online at www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is conducted with full knowledge of the FDA.
