FDA recall D-0564-2016

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.

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

Kentucky

Key facts

Status

Terminated

Initiation date

2015-10-29

Report date

2016-01-13

Termination date

2016-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Utica, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0564-2016