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Recall Observatory FDA recall evidence

Drug product

Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.

D-1390-2012

April 05, 2012

Class III

Product summary

Firm
Hospira, Inc.
Event
Event 62053
Status
Terminated
Classification
Class III
Quantity
164,568 containers
Official record key
drug-enforcement:D-1390-2012

Official wording

Reason: Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.

Code information: Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent