June 2014 FDA Recall Drug by Mckesson Packaging Services
D-1483-2014 - Failed Dissolution Specification; at the 12 month time interval.

This Class III drug recall was voluntarily initiated by Mckesson Packaging Services on June 19, 2014 for the product Drug. The FDA reported the reason for recall as failed dissolution specification; at the 12 month time interval.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1483-2014

Reason for Recall
Failed Dissolution Specification; at the 12 month time interval.
Initiated
06-19-2014
Reported
08-06-2014
Quantity
1,511,250 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68652
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.
Mckesson Packaging Services
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.
04-27-2017
Product Description About Product Description
Full technical description of the product.
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC

Batch or Lot Expiration Information

Lot# Lot 0093943