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Class III: unlikely to cause harmTerminated

Pq EPSOM SALT(Magnesium Sulfate Heptahydrate Recall

EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufac…

PQ Corporation · Utica, IL

Risk level
Class III
Reported by FDA
Jan 13, 2016
Recall ID
D-0564-2016
Check your lot numberHow we source this data

Summary

Pq recalled EPSOM SALT(Magnesium Sulfate Heptahydrate starting Oct 29, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0564-2016 on Jan 13, 2016. Reason: 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)). Status: Terminated.

Why it was recalled

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)).

Product description

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.

Lot numbers, UPCs & expiration codes

Lot # U150511; Exp. 05/18

Where it was sold

Kentucky

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0564-2016
Classification
Class III
Status
Terminated
Recall initiated
Oct 29, 2015
FDA report date
Jan 13, 2016
Quantity
41,650 lbs. (833 bags)
Recall type
Voluntary: Firm initiated
Recalling firm
PQ Corporation

Original FDA data

Every field from FDA enforcement report D-0564-2016, exactly as published.

Show all FDA fields
City
Utica
State
IL
Status
Terminated
Country
United States
Event ID
72639
Address
340 E Grove St
Code information
Lot # U150511; Exp. 05/18
Postal code
61373-9001
Report date
Jan 13, 2016
Product type
Drugs
Recall number
D-0564-2016
Classification
Class III
Recalling firm
PQ Corporation
Product quantity
41,650 lbs. (833 bags)
Termination date
Dec 21, 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)).
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Kentucky
Recall initiation date
Oct 29, 2015
Initial firm notification
E-Mail
Center classification date
Jan 7, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0564-2016, published Jan 13, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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