The Recall Desk
LowFDA (Drugs)·D-0564-2016·Announced 2016-01-13

PQ Corporation Recalls Epsom Salt Bags Due to High Iron Levels

PQ Corporation is recalling 50 lb bags of Epsom Salt because iron levels exceeded USP limits. The product was distributed in Kentucky.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor issues.

Plain-English summary

PQ Corporation is recalling 41,650 lbs (833 bags) of Epsom Salt (Magnesium Sulfate Heptahydrate, USP) in 50 lb multi-wall bags. The recall is due to failed impurities and degradation specifications, specifically because the level of iron exceeds the limit set by the USP monograph (USP limit is NMT 0.5 ug/g).

The affected product is Lot # U150511 with an expiration date of 05/18. The product was distributed in Kentucky. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this product should stop using it and contact PQ Corporation for further instructions or a refund.

The recalled product

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.
Manufacturer
PQ Corporation
Category
Drug — Pharmaceutical Ingredient
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # U150511
  • Exp. 05/18

Distribution

Distributed in 1 state:

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