Multi-event July 2019 FDA Recall Nitrofurantoin Monohydrate/ Macrocrystalline by Alvogen, Inc
This Multi-event Class II drug recall was voluntarily initiated by Alvogen, Inc on July 24, 2019 for the product Nitrofurantoin Monohydrate/ Macrocrystalline. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Natonwide, PR and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1723-2019
Failed dissolution specifications
07-24-2019
08-21-2019
4272 bottles
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.
Natonwide, PR
08-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01
Batch or Lot Expiration Information
Lot# 472990, Exp 03/2020
Affected Packages Involved in this Recall
Recall Number: D-1722-2019
Failed dissolution specifications
07-24-2019
08-21-2019
2784 bottles
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.
Natonwide, PR
08-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Batch or Lot Expiration Information
Lot# 471976, Exp 03/2020
