August 2017 FDA Recall Drug by Mckesson Packaging Services
D-1128-2017 - Failed moisture limits

This Class III drug recall was voluntarily initiated by Mckesson Packaging Services on August 28, 2017 for the product Drug. The FDA reported the reason for recall as failed moisture limits. The product was distributed in PA, OH, IL, CO, LA and the recall is currently terminated.

Recall Number: D-1128-2017

Reason for Recall
Failed moisture limits: Out of specification for moisture content.
Initiated
08-28-2017
Reported
09-13-2017
Quantity
3966 unit-dose boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78020
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.
PA, OH, IL, CO, LA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2020
Product Description About Product Description
Full technical description of the product.
Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10

Batch or Lot Expiration Information

Lot# : 0112313 Exp. 12/2017; 0113376 Exp. 06/2018; 0113645 Exp. 02/2019.