D-0564-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 13, 2016
- Initiation Date
- October 29, 2015
- Termination Date
- December 21, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41,650 lbs. (833 bags)
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.
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)).
Distribution Pattern
Kentucky
Code Information
Lot # U150511; Exp. 05/18