Febuxostat Tablet, Film Coated
FDA Recall NDC 16714-059
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Febuxostat (NDC 16714-059). A significant event, classified as Class II, was initiated on Mar 04, 2024 by Northstar Rxllc. The reported reason for this action was: "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Mar 04, 2024
Mar 20, 2024
7,488 bottles
Recall Profile & Regulatory Data
Event ID
94142
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# : DNE0894A, Exp 07/31/2025
Affected Packages Involved in this Recall
16714-059-01Product
16714-060-01Product
Class II Ongoing
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Mar 04, 2024
Mar 20, 2024
47,520 bottles
Recall Profile & Regulatory Data
Event ID
94142
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# s: DNE0865A, DNE0866A, Exp 06/30/2025
Affected Packages Involved in this Recall
16714-059-01Product
16714-060-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
