FDAClass IIIJanuary 13, 2016

Magnesium Sulfate 7-Hydrate recall: Impurity Out of Spec

Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center…

Why was Magnesium Sulfate 7-Hydrate recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.

Product
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center…
Recalling firm
Avantor Performance Materials Inc
Quantity
265 Drums
Distribution
Distributed in the US including: CA, IL & NC; Canada
Recall date
January 13, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls