Thyroid Medication TIROSINT Levothyroxine Sodium Nationwide Recall for Subpotency
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. Two lot numbers are affected: Lot #220407 (Exp. 10/2023) and Lot #220960 (Exp. 03/2024).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II prescription drug recall for subpotency of a critical thyroid medication, creating a risk-of-harm for patients dependent on proper dosing. No illnesses or injuries are reported in the source text, making this a risk-of-harm scenario without reported injury, which scores as 3 per the rubric.
Plain-English summary
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution, a prescription thyroid medication. The affected product is a 50 microgram/mL oral solution supplied as 6 pouches containing 5 ampules each. Two lot numbers are involved: Lot #220407 with expiration date October 2023 and Lot #220960 with expiration date March 2024. The product was distributed nationwide in the United States.
The recall was initiated because the affected batches are subpotent, meaning they contain less levothyroxine sodium than labeled. This could result in patients receiving insufficient thyroid hormone replacement.
Patients currently taking TIROSINT should contact their healthcare provider or pharmacist to determine if their medication is affected. Do not stop taking levothyroxine without consulting your healthcare provider, as interrupting thyroid replacement therapy can have serious health consequences.
This voluntary recall was initiated by the manufacturer on January 30, 2023, and was terminated on October 31, 2023, indicating that the recall action has been completed.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- IBSA PHARMA INC
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 220407
- Exp. 10/2023
- 220960
- Exp. 03/2024.
UPCs (15)
- 0371858011754
- 0371858013055
- 0371858012553
- 0371858011556
- 0371858015554
- 0371858013550
- 0371858015059
- 0371858014052
- 0371858016056
- 0371858014557
- 0371858010559
- 0371858011358
- 0371858011259
- 0371858011051
- 0371858012058
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TIROSINT
- HighLevothyroxine Oral Solution TIROSINT Recalled Due to Subpotency
FDA (Drugs) · 2023-03-01
- ModerateTIROSINT Levothyroxine Oral Solution Recalled for Subpotency
FDA (Drugs) · 2023-03-01
- HighThyroid Drug TIROSINT Recalled Due to Subpotent Formulation
FDA (Drugs) · 2023-03-01
- HighPrescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency
FDA (Drugs) · 2023-03-01
- HighLevothyroxine sodium oral solution recalled nationwide for subpotent dosing
FDA (Drugs) · 2023-03-01
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