# FDA recall D-0368-2024

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2024-03-04.

## Product

Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.

## Reason for recall

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0368-2024
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-03-04
- **Report date:** 2024-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2024

## Citation

> AI Analytics. FDA recall D-0368-2024. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0368-2024. Source: US FDA. Licensed CC0.

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