December 2018 FDA Recall Nitrofurantoin by Lupin Somerset
D-0346-2019 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Lupin Somerset on December 21, 2018 for the product Nitrofurantoin. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0346-2019

Reason for Recall
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Initiated
12-21-2018
Reported
01-09-2019
Quantity
23,460 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81865
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 in the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-15-2023
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, NDC 43386-450-11.

Batch or Lot Expiration Information

Lot# : S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19.

Affected Packages Involved in this Recall

43386-450-11 Nitrofurantoin