April 2015 FDA Recall Drug by Romark Laboratories, L.c.
D-0983-2015 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Romark Laboratories, L.c. on April 24, 2015 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0983-2015

Reason for Recall
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Initiated
04-24-2015
Reported
05-13-2015
Quantity
32,893 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70914
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.
Romark Laboratories, L.C.
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-25-2016
Product Description About Product Description
Full technical description of the product.
Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607

Batch or Lot Expiration Information

Lot# : MTEW1721, MTCW21281, MTCW21291, Exp 09/2016
Lot# : MTEW5791, Exp 12/2016
Lot# : MTEW5801, Exp 01/2017.