TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for
Summary
The FDA issued a Class II for TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches by IBSA PHARMA INC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0345-2023
Action Date
2023-03-01
Status
Terminated
Category
drug
Product Description
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 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 71858-0160-5
Lot/Code Info: Lot #: 220418, Exp. 10/2023; 220560, Exp. 11/2023.
Quantity Affected: N/A
Reason for Recall
Subpotent Drug
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-30
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 97 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
IBSA PHARMA INC has 15 FDA actions in our database, including 15 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IBSA PHARMA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IBSA PHARMA INC have FDA actions?
IBSA PHARMA INC has 15 FDA actions in our database, including 15 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0345-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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