Nationwide Recall of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Potency - MedWaste Management Nationwide Recall of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Potency - MedWaste Management

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Nationwide Recall of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Potency

IBSA Pharma Inc. has issued an immediate recall of a large number of batches of the medication TIROSING®-SOL due to potency issues. The affected lots have been found to be less potent than labeled, putting consumers at risk of decreasing T4 levels and return of their hypothyroid symptoms.

SUMMARY

Date of Recall:

Announced: January 31, 2023

Public Notification: February 1, 2023

Name(s) of Drug:

TIROSINT®-SOL

Levothyroxine Sodium Solution

(CAPSULES NOT AFFECTED. RECALL APPLIES TO SOLUTION ONLY)

Company Name:

IBSA Pharma Inc.

Drug Indication:

Hypothyroidism

Pituitary Thyrotropin Suppression

Thyroid Cancer (adjunct medication)

 

Product Description

TIROSINT®-SOL is a clear, odorless solution that is packaged in individual ampules for oral consumption. Each ampule is individually labeled with the product name and dosage. Each box of ampules is labeled with further information such as the NDS numbers, lot numbers, and expiration dates. This recall effects several different dosages of the medication, therefore all consumers of this product should confirm if their particular lots are listed.

Reason for Recall

The labeled amount of levothyroxine sodium in each ampule has been found to be less than 95% of what is indicated on the label. Particularly for patients who are sensitive to minor changes in their T4 levels, or patients who only take the medication on a weekly or bi-weekly basis, this variation in potency could lead to serious side effects.

Impacts

Consumers who have received an effected batch of the medication and who continue to utilize it may experience symptoms related to decreased T4 such as fatigue, increased sensitivity to cold, constipation, dry skin, slow heart rate, depression, swelling of the thyroid gland, puffy face, and/or hair loss.

Lot information

Consumers should locate the box in which the medication comes to compare NDC and lot numbers as well as expiration dates with the chart below. If you find your NDC number, lot number and expiration date on the chart below, your medication is affected by the recall and you will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.

Note: Each strength is highlighted in a different color. Your box may have varying coloring, but you will find the NDC, Lot Number and Expiration Date in the same area on each package.

Product Description NDC Lot Number Expiration Date
TIROSINT-SOL 13 mcg/mL 30 units carton-box 71858-0105-5 220409 10/2023
TIROSINT-SOL 13 mcg/mL 30 units carton-box 71858-0105-5 220956 03/2024
TIROSINT-SOL 25 mcg/mL 30 units carton-box 71858-0110-5 220856 02/2024
TIROSINT-SOL 37.5 mcg/mL 30 units carton-box 71858-0112-5 220552 11/2023
TIROSINT-SOL 37.5 mcg/mL 30 units carton-box 71858-0112-5 221055 04/2024
TIROSINT-SOL 44 mcg/mL 30 units carton-box 71858-0113-5 220553 11/2023
TIROSINT-SOL 44 mcg/mL 30 units carton-box 71858-0113-5 221056 04/2024
TIROSINT-SOL 50 mcg/mL 30 units carton-box 71858-0115-5 220407 10/2023
TIROSINT-SOL 50 mcg/mL 30 units carton-box 71858-0115-5 220960 03/2024
TIROSINT-SOL 62.5 mcg/mL 30 units carton-box 71858-0117-5 220556 11/2023
TIROSINT-SOL 62.5 mcg/mL 30 units carton-box 71858-0117-5 221058 04/2024
TIROSINT-SOL 75 mcg/mL 30 units carton-box 71858-0120-5 220853 02/2024
TIROSINT-SOL 88 mcg/mL 30 units carton-box 71858-0125-5 220411 10/2023
TIROSINT-SOL 88 mcg/mL 30 units carton-box 71858-0125-5 220854 02/2024
TIROSINT-SOL 100 mcg/mL 30 units carton-box 71858-0130-5 220413 10/2023
TIROSINT-SOL 100 mcg/mL 30 units carton-box 71858-0130-5 220964 03/2024
TIROSINT-SOL 112 mcg/mL 30 units carton-box 71858-0135-5 220414 10/2023
TIROSINT-SOL 112 mcg/mL 30 units carton-box 71858-0135-5 220852 02/2024
TIROSINT-SOL 112 mcg/mL 30 units carton-box 71858-0135-5 220970 03/2024
TIROSINT-SOL 125 mcg/mL 30 units carton-box 71858-0140-5 220855 02/2024
TIROSINT-SOL 137 mcg/mL 30 units carton-box 71858-0145-5 220415 10/2023
TIROSINT-SOL 137 mcg/mL 30 units carton-box 71858-0145-5 221052 04/2024
TIROSINT-SOL 150 mcg/mL 30 units carton-box 71858-0150-5 220959 03/2024
TIROSINT-SOL 175 mcg/mL 30 units carton-box 71858-0155-5 220416 10/2023
TIROSINT-SOL 175 mcg/mL 30 units carton-box 71858-0155-5 221053 04/2024
TIROSINT-SOL 200 mcg/mL 30 units carton-box 71858-0160-5 220418 10/2023
TIROSINT-SOL 200 mcg/mL 30 units carton-box 71858-0160-5 220560 11/2023

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY. SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.

Discontinuation of this medication may cause symptoms of hypothyroidism to return in a prompt and sometimes serious way. These may include:

  • Bradycardia (slowed heart rate)
  • Depression
  • Fatigue
  • Constipation
  • Muscle weakness
  • Irregular or heavy menstrual cycles
  • Weight gain
  • Difficulty tolerating cold
  • Memory deficits
  • Puffy face
  • Dry skin
  • Thinning hair

If you find that your lot of medication is part of this recall, do the following:

  1. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
  2. Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
  3. Consumers should contact IBSA Pharma Inc. at 1-800-587-3513. They are available Mon-Fri from 9:00am to 7:00pm (EST). You can also contact them via email at medinfo@ibsapharma.com.
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock that is affected by the recall immediately.
  2. Contact IBSA Pharma Inc at 1-855-224-0231 or you can utilize IBSACS@Eversana.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock that is affected by the recall immediately.
  2. Contact IBSA Pharma Inc at 1-855-224-0231 or you can utilize IBSACS@Eversana.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

 

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