April 2013 FDA Recall Drug by Unique Pharmaceutical, Ltd
D-1587-2014 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Unique Pharmaceutical, Ltd on April 17, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in TN, PA, and TX and the recall is currently terminated.

Recall Number: D-1587-2014

Reason for Recall
Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
Initiated
04-17-2013
Reported
09-24-2014
Quantity
430 Bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67904
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.
Unique Pharmaceutical, Ltd
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.
TN, PA, and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2016
Product Description About Product Description
Full technical description of the product.
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502

Batch or Lot Expiration Information

Lot# 00083844 Exp. 07/13