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 |
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:
- Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
- Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
- 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.
- 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.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- 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.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- 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.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
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