Recall: D-1082-2015

Class II - Potentially Harmful

Class IIClassification

2015-04-21Initiated

TerminatedStatus

Alvogen, IncFirm

Product

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

Reason

Failed Dissolution Specification; 6 month time point

Distribution

Nationwide and Puerto Rico

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