Leading Pharma, LLC: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Leading Pharma, LLC
- Product
- Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
- Reason / hazard
- CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-03-20
- Code info
- Lots# H03125, H03225, H03325, Exp Date: 2027/08
- Product quantity
- 9384 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Fairfield
- State
- NJ
- Country
- United States
- Event id
- 98628
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