Recalls / Class II
Class IID-0339-2023
Product
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 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 71858-0117-5
- Brand name
- Tirosint
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 71858-0105, 71858-0110, 71858-0112, 71858-0113, 71858-0115, 71858-0117, 71858-0120, 71858-0125, 71858-0130, 71858-0135 +5 more
- FDA application
- NDA206977
- Affected lot / code info
- Lot #: 220556, Exp. 11/2023; 221058, Exp. 04/2024.
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- IBSA PHARMA INC
- Manufacturer
- IBSA Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8 Campus Dr Ste 201, N/A, Parsippany, New Jersey 07054-4409
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-01-30
- FDA classified
- 2023-04-04
- Posted by FDA
- 2023-03-01
- Terminated
- 2023-10-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0339-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.