June 2018 FDA Recall Nitrofurantoin by Lupin Somerset
D-0927-2018 - Subpotent Drug and Failed Content Uniformity.

This Class II drug recall was voluntarily initiated by Lupin Somerset on June 28, 2018 for the product Nitrofurantoin. The FDA reported the reason for recall as subpotent drug and failed content uniformity.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0927-2018

Reason for Recall
Subpotent Drug and Failed Content Uniformity.
Initiated
06-28-2018
Reported
07-18-2018
Quantity
3456 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80377
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
LUPIN SOMERSET
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-06-2023
Product Description About Product Description
Full technical description of the product.
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11

Batch or Lot Expiration Information

Lot# : S700065, Exp. 02/2019; 700619, Exp. 08/2019

Affected Packages Involved in this Recall

43386-450-11 Nitrofurantoin