D-0368-2024 Class II Ongoing
FDA drug recall D-0368-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Mar 4, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. The recall status is ongoing. Affected quantity: 47,520 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 20, 2024
- Initiation Date
- Mar 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,520 bottles
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.
Reason for Recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Distribution Pattern
Nationwide
Code Information
Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0368-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026