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Recall Observatory FDA recall evidence

Drug product

Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1068-2018

May 17, 2018

Class II

Product summary

Firm
Guardian Pharmacy Services
Event
Event 80118
Status
Terminated
Classification
Class II
Quantity
100 50-ml vials
Official record key
drug-enforcement:D-1068-2018

Official wording

Reason: Lack of sterility assurance.

Code information: Lot: 58653:42 Use By: 06/12/2018; 58773/58766 Use By: 06/21/2018; 58766:42 Use By: 06/20/2018;

Distribution pattern: Texas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility