Alvogen, Inc recalls Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pin…

Recall date

July 24, 2019

Source

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

Recall number

D-1722-2019

FDA classification

Class II

Brand / firm

Alvogen, Inc

Sold / distributed

Natonwide, PR

Why it was recalled

Failed dissolution specifications

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