April 2015 FDA Recall Nitrofurantoin Monohydrate/ Macrocrystalline by Alvogen, Inc
D-1082-2015 - Failed Dissolution Specification; 6 month time point
This Class II drug recall was voluntarily initiated by Alvogen, Inc on April 21, 2015 for the product Nitrofurantoin Monohydrate/ Macrocrystalline. The FDA reported the reason for recall as failed dissolution specification; 6 month time point. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1082-2015
Failed Dissolution Specification; 6 month time point
04-21-2015
05-20-2015
13,392 bottles (100 count)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alvogen, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
12-04-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lot 457529, exp. 08/2016
