October 2015 FDA Recall Drug by Pq Corporation
D-0564-2016 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Pq Corporation on October 29, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Kentucky and the recall is currently terminated.

Recall Number: D-0564-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
Initiated
10-29-2015
Reported
01-13-2016
Quantity
41,650 lbs. (833 bags)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72639
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.
PQ Corporation
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Kentucky
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-21-2016
Product Description About Product Description
Full technical description of the product.
EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.

Batch or Lot Expiration Information

Lot# U150511; Exp. 05/18