D-0486-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2026
- Initiation Date
- March 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9384 bottles
Product Description
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Reason for Recall
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Distribution Pattern
US Nationwide.
Code Information
Lots# H03125, H03225, H03325, Exp Date: 2027/08