June 2015 FDA Recall Drug by Glaxosmithkline Consmer Healthcare
D-1287-2015 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Glaxosmithkline Consmer Healthcare on June 30, 2015 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Puerto Rico and Virgin Islands and the recall is currently terminated.

Recall Number: D-1287-2015

Reason for Recall
Failed Dissolution Specifications
Initiated
06-30-2015
Reported
08-12-2015
Quantity
17,675 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71717
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GlaxoSmithkline Consmer Healthcare
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.
Puerto Rico and Virgin Islands
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-28-2017
Product Description About Product Description
Full technical description of the product.
Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108

Batch or Lot Expiration Information

Lot# a) 13034 exp 10/31/15, 13222 and 13337 exp 11/30/15, 13611 and 13760 exp 2/29/15, 13953 exp 4/30/16, and 14542 exp 1/31/17; b) BT10114001 and BT10115001A exp 2/1/18, 13316 and 13438 exp 11/30/15 and 13880 exp 2/29/16; c) 13298 exp 11/30/15 and 13759 exp 4/30/16