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Cipla USA, Inc.: Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: C

DrugsSource: FDA (drug) · Date: 2026-10-14

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Cipla USA, Inc.
Product
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.
Reason / hazard
Failed Impurities/Degradation Specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide.
Recall initiated
2026-09-18
Code info
Lot#: 5KA0405, Exp 12/31/2026.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Warren
State
NJ
Country
United States
Event id
99930
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