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Recall Observatory FDA recall evidence

Drug product

Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA

D-866-2013

March 25, 2013

Class II

Product summary

Firm
Pallimed Solutions
Event
Event 64716
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-866-2013

Official wording

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information: All lots within expiry

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility