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Recall Observatory FDA recall evidence

Drug product

Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743.

D-1656-2012

May 08, 2012

Class III

Product summary

Firm
Morton Salt Co.
Event
Event 61818
Status
Terminated
Classification
Class III
Quantity
531,950 lbs
Official record key
drug-enforcement:D-1656-2012

Official wording

Reason: Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.

Code information: Lot #: OCT251BC01, NOV041BA01 & NOV071BA01.

Distribution pattern: Nationwide & PR & Ireland.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification