Drug product
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
D-0486-2026
Product summary
- Event
- Event 98628
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9384 bottles
- Official record key
drug-enforcement:D-0486-2026
Official wording
Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Code information: Lots# H03125, H03225, H03325, Exp Date: 2027/08
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations