Drug recall: TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for…
Class II FDA enforcement event 91556. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Subpotent Drug
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
IBSA PHARMA INC started this drug recall on 30 Jan 2023. The firm address in the FDA record is in Parsippany, NJ. FDA put the recall in Class II. FDA event 91556 has 15 product records. The first FDA enforcement report date is 1 Mar 2023. The record gives the status Terminated, with the termination date 31 Oct 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA.
Recalling firm
IBSA PHARMA INC, Parsippany, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
15 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0331-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 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 71858-0105-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0332-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 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 71858-0130-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0333-2023 | 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 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0334-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 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 71858-0155-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0335-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 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 71858-0110-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0336-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 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 71858-0112-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0337-2023 | 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 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0338-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 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 71858-0115-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0339-2023 | 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 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0340-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 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 71858-0120-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0341-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 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 71858-0125-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0342-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 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 71858-0135-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0343-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 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 71858-0145-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0344-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 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 71858-0150-5 | N/A | Class II | Terminated | 1 Mar 2023 |
| D-0345-2023 | 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 | N/A | Class II | Terminated | 1 Mar 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2023
- 281
- Share of these events in Class II
- 59%
- Product records in this event
- 15
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0331-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 91556. https://recallregister.com/fda/ii/91556/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA.
- What quantity of product is in FDA event 91556?
- The event has 15 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2023 have the same class?
- 59% of the 281 drug events that started in 2023 are in Class II.