Recall: D-1722-2019

Class II - Potentially Harmful

Class IIClassification

2019-07-24Initiated

TerminatedStatus

Alvogen, IncFirm

Product

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

Reason

Failed dissolution specifications

Distribution

Natonwide, PR

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.