FDA recall D-0563-2016

Product

Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specifications results for impurities.

Distribution

Distributed in the US including: CA, IL & NC; Canada

Key facts

Status

Terminated

Initiation date

2015-10-30

Report date

2016-01-13

Termination date

2016-12-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0563-2016