Class II
Ongoing
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.
This recall is currently active, issued March 20, 2024. It was issued by Sun Pharmaceutical Industries Inc.
- Recall Initiated
- March 4, 2024
- Posted
- March 20, 2024
- Recall Number
- D-0369-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7,488 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Distribution
Nationwide
Lot / Code Info
Lot #: DNE0894A, Exp 07/31/2025
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