Reported Feb 28, 2024 · Ongoing

Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,…

Ascend Laboratories, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ascend Laboratories, LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707

Is this the product you have?

  • Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only
  • Manufactured byAlkem Laboratories Ltd., INDIA
  • Distributed byAscend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
Lot codes and dates
    • lOTS #: 22121458
    • 22121459
    • 22121460
    • 22121461
    • 22121462
    • 22121463
    • 22121464
    • Exp 4/2024
    • 22121176
    • 22121407
    • 22121465
    • Exp 3/2024
    • 22121761
    • 22121762
    • 22121763
    • 22121764
    • 22121766
    • 22121968
    • 22121969
    • Exp 5/2024
Amount recalled
71,244 sachets

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specification: Out of specification for organic impurities

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:05 PM UTC

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