Reported May 20, 2015 · Terminated

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc.…

Alvogen, Inc.

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: Alvogen, Inc · 10 Bloomfield Ave Bldg B Ste 2 · Pine Brook, NJ · 07058-9743

Is this the product you have?

  • NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Lot codes and dates
    • Lot 457529
    • exp. 08/2016
Amount recalled
13,392 bottles (100 count)

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Dissolution Specification; 6 month time point

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 Dec 4, 2015 · Data as of Sep 19, 7:18 PM UTC

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