FDAFDA · Food and drugs·Recall number D-0369-2024
Febuxostat Tablets 80mg, 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 16714-060-01.
Published March 20, 2024 · Recall initiated: March 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FEBUXOSTAT
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide
- UPC
- 0316714060019
- Lot
- Lot #: DNE0894A, Exp 07/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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