FDA-Drug2015-05-20Class II
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Alvogen, Inc
Hazard
Failed Dissolution Specification; 6 month time point
Sold states
Nationwide and Puerto Rico
Affected count
13,392 bottles (100 count)
Manufactured in
10 Bloomfield Ave Bldg B Ste 2, N/A, Pine Brook, NJ, United States
Products
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2015Don't want to check this manually?
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