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Recall Observatory FDA recall evidence

Drug product

Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1059-2018

May 17, 2018

Class II

Product summary

Firm
Guardian Pharmacy Services
Event
Event 80118
Status
Terminated
Classification
Class II
Quantity
442 1-ml syringes
Official record key
drug-enforcement:D-1059-2018

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 58895:42 Use By: 06/27/2018; 58856:42 Use By: 06/21/2018;

Distribution pattern: Texas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility