October 2014 FDA Recall Drug by Contract Packaging Resources Inc.
D-0248-2015 - Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP

This Class II drug recall was voluntarily initiated by Contract Packaging Resources Inc. on October 10, 2014 for the product Drug. The FDA reported the reason for recall as correct labeled product mispacked; correct labeled bottles of assured ibuprofen softgels were packaged into cartons of assured naproxen sodium tablets, usp. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0248-2015

Reason for Recall
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Initiated
10-10-2014
Reported
11-19-2014
Quantity
11,640 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69554
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.
Contract Packaging Resources Inc.
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-05-2016
Product Description About Product Description
Full technical description of the product.
Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320

Batch or Lot Expiration Information

Lot# Lot FH4102A UPC #639277223685, Exp. Date 3/16