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Recall Observatory FDA recall evidence

Drug 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.

D-0563-2016

October 30, 2015

Class III

Product summary

Firm
Avantor Performance Materials Inc
Event
Event 72818
Status
Terminated
Classification
Class III
Quantity
265 Drums
Official record key
drug-enforcement:D-0563-2016

Official wording

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

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

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications