FDA Recalls TIROSINT Levothyroxine Sodium Lot 220853 for Subpotency
IBSA Pharma Inc. recalled TIROSINT levothyroxine sodium lot 220853 nationwide due to subpotency. The oral solution may contain less active ingredient than labeled, potentially affecting thyroid hormone replacement therapy.
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: FDA Class II recall of subpotent levothyroxine, a risk-of-harm product where patients may not receive adequate thyroid hormone replacement. No illnesses or injuries are reported. Per rubric: risk-of-harm products where injury has not yet been reported score at most 3.
Plain-English summary
IBSA Pharma Inc. initiated a recall of TIROSINT (levothyroxine sodium) Oral Solution, 75 microgram/mL, lot number 220853 with an expiration date of February 2024. The product was distributed nationwide in the United States.
The recall was initiated because the medication was found to be subpotent, meaning it contains less of the active ingredient than the labeled amount. This Class II recall was voluntary and initiated by the firm.
Patients who have used this medication should consult their healthcare provider. Healthcare providers and pharmacies should stop dispensing this lot and help patients obtain replacement medication.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- IBSA PHARMA INC
- Hazard
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 (2)
- Lot #: 220853
- Exp. 02/2024.
UPCs (15)
- 0371858011754
- 0371858013055
- 0371858012553
- 0371858011556
- 0371858015554
- 0371858013550
- 0371858015059
- 0371858014052
- 0371858016056
- 0371858014557
- 0371858010559
- 0371858011358
- 0371858011259
- 0371858011051
- 0371858012058
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by IBSA PHARMA INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same brand · TIROSINT
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Same manufacturer · IBSA PHARMA INC
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- ModerateTIROSINT Levothyroxine Oral Solution Recalled for Subpotency
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- HighLevothyroxine oral solution TIROSINT recalled nationwide for subpotency
FDA (Drugs) · 2023-03-01
- HighFDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01
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