FDA recall D-0337-2023

IBSA PHARMA INC · Class II · drug

Product

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 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 71858-0113-5

Reason for recall

Subpotent Drug

Distribution

Nationwide in the USA.

Key facts

Status
Terminated
Initiation date
2023-01-30
Report date
2023-03-01
Termination date
2023-10-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2023