May 2012 FDA Recall Drug by Morton Salt Co.
D-1656-2012 - Impurities/Degradation Products

This Class III drug recall was voluntarily initiated by Morton Salt Co. on May 8, 2012 for the product Drug. The FDA reported the reason for recall as impurities/degradation products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1656-2012

Reason for Recall
Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
Initiated
05-08-2012
Reported
08-29-2012
Quantity
531,950 lbs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61818
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.
Morton Salt Co.
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 & PR & Ireland.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-01-2013
Product Description About Product Description
Full technical description of the product.
Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743.

Batch or Lot Expiration Information

Lot# : OCT251BC01, NOV041BA01 & NOV071BA01.