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

Recall date

April 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1082-2015

FDA classification

Class II

Brand / firm

Alvogen, Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Failed Dissolution Specification; 6 month time point

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01