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Recall Observatory FDA recall evidence

Drug product

Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1067-2018

May 17, 2018

Class II

Product summary

Firm
Guardian Pharmacy Services
Event
Event 80118
Status
Terminated
Classification
Class II
Quantity
60 20-ml syringes
Official record key
drug-enforcement:D-1067-2018

Official wording

Reason: Lack of sterility assurance.

Code information: Lot: 58758; 58760; 58756, 59095:42, 59093:42; 59091:42

Distribution pattern: Texas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility