FDA recall D-1082-2015

Alvogen, Inc · Class II · drug

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 for recall

Failed Dissolution Specification; 6 month time point

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-04-21
Report date: 2015-05-20
Termination date: 2015-12-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pine Brook, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2015