Class I · High risk
Thyroid Tablets
Superpotent Drug
Tirosint - Sol (Levothyroxine Sodium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0135-5
Affected NDC
71858-0135-05
Compare with the code on your package — it is the most precise check available.
Drug: Levothyroxine Category: Thyroid Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tirosint SOL Levothyroxine Sodium NDC 71858-0135 |
112 ug/mL | Solution Oral |
IBSA Pharma Inc. | Rx |
- Recalling firm
- Ibsa Pharma INC
- NDC code
- 71858-0135-5
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0342-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Levothyroxine recalls
See all
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Other recalls by Ibsa Pharma INC
All 2023 recalls
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
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