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

FDA recall notice · announced May 20, 2015 · Alvogen

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot 457529, exp. 08/2016
Quantity: 13,392 bottles (100 count)
Status: Terminated
Products in this recall event:
- NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01 (D-1082-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.