US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 24, 2019 (7 years ago)

Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed dissolution specifications

What was recalled

Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01

Recalling firm
Alvogen, Inc
NDC code
47781-303-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1722-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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