Drug 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
D-0339-2023
Product summary
- Firm
- IBSA PHARMA INC
- Event
- Event 91556
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0339-2023
Official wording
Reason: Subpotent Drug
Code information: Lot #: 220556, Exp. 11/2023; 221058, Exp. 04/2024.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Subpotent