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Recall Observatory FDA recall evidence

Drug product

C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117

D-0718-2021

May 11, 2021

Class I

Product summary

Firm
People's Custom Rx and Clinical Care, LLC
Event
Event 88340
Status
Terminated
Classification
Class I
Quantity
14 vials
Official record key
drug-enforcement:D-0718-2021

Official wording

Reason: Non-Sterility

Code information: Lot: 11649 BUD: 07/07/2021

Distribution pattern: MS, TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility