Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Material...
FDA Recall #D-0563-2016 — Class III — October 30, 2015
Product Description
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.
Recalling Firm
Avantor Performance Materials Inc — Center Valley, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
265 Drums
Distribution
Distributed in the US including: CA, IL & NC; Canada
Code Information
Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated