Drug 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.
D-0564-2016
Product summary
- Firm
- PQ Corporation
- Event
- Event 72639
- Status
- Terminated
- Classification
- Class III
- Quantity
- 41,650 lbs. (833 bags)
- Official record key
drug-enforcement:D-0564-2016
Official wording
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)).
Code information: Lot # U150511; Exp. 05/18
Distribution pattern: Kentucky
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications