Why it was recalled
Subpotent Drug
Product description
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 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 71858-0125-5
Lot numbers, UPCs & expiration codes
Lot #: 220411, Exp. 10/2023; 220854, Exp. 02/2024.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0341-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 30, 2023
- FDA report date
- Mar 1, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- IBSA PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0341-2023, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91556
- Address
- 8 Campus Dr Ste 201
- Code information
- Lot #: 220411, Exp. 10/2023; 220854, Exp. 02/2024.
- Postal code
- 07054-4409
- Report date
- Mar 1, 2023
- Product type
- Drugs
- Recall number
- D-0341-2023
- Classification
- Class II
- Recalling firm
- IBSA PHARMA INC
- Termination date
- Oct 31, 2023
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 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 71858-0125-5
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jan 30, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2023