# FDA recall D-0342-2023

> **IBSA PHARMA INC** · Class II · drug recall initiated 2023-01-30.

## Product

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

## Reason for recall

Subpotent Drug

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0342-2023
- **Recalling firm:** IBSA PHARMA INC
- **Classification:** Class II
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0342-2023

## Citation

> AI Analytics. FDA recall D-0342-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0342-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*