July 2012 FDA Recall Drug by Lnk International, Inc.
D-0319-2015 - Incorrect/Undeclared Excipients

This Class II drug recall was voluntarily initiated by Lnk International, Inc. on July 18, 2012 for the product Drug. The FDA reported the reason for recall as incorrect/undeclared excipients. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0319-2015

Reason for Recall
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Initiated
07-18-2012
Reported
12-31-2014
Quantity
9,379 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62613
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.
LNK International, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-23-2014
Product Description About Product Description
Full technical description of the product.
Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925

Batch or Lot Expiration Information

Lot# Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14