Reported May 13, 2015 · Terminated

Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin…

Romark Laboratories, L.C.

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: Romark Laboratories, L.C. · 3000 Bayport Dr Ste 200 · Tampa, FL · 33607-8416

Is this the product you have?

  • Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607
Lot codes and dates
    • Lot #: MTEW1721
    • MTCW21281
    • MTCW21291
    • Exp 09/2016
    • Lot #: MTEW5791
    • Exp 12/2016
    • Lot #: MTEW5801
    • Exp 01/2017
Amount recalled
32,893 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity

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

Notice updated Oct 25, 2016 · Data as of Sep 19, 7:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.