Drug Enforcement D-0333-2023

Subpotent Drug

Status

Terminated

Classification

Class II

Report Date

March 1, 2023

Termination Date

October 31, 2023

Product Information

Product description
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 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 71858-0140-5
Product quantity
N/A
Reason for recall
Subpotent Drug
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
IBSA PHARMA INC
Address
8 Campus Dr Ste 201, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0333-2023
Event ID
91556
Recall initiation date
January 30, 2023
Center classification date
April 4, 2023
Code info
Lot #: 220855, Exp. 2/2024.
More code info