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Recall Observatory FDA recall evidence

Drug product

Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1061-2018

May 17, 2018

Class II

Product summary

Firm
Guardian Pharmacy Services
Event
Event 80118
Status
Terminated
Classification
Class II
Quantity
60 5-ml vials
Official record key
drug-enforcement:D-1061-2018

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 58611:42 Use By: 06/07/2018; 59099:42 Use By: 07/24/2018; 58786:42 Use By: 06/24/2018

Distribution pattern: Texas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility