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Recall Observatory FDA recall evidence

Drug product

GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0092-2016

July 24, 2015

Class II

Product summary

Firm
JD & SN Inc., dba Moses Lake Professional Pharmacy
Event
Event 71806
Status
Terminated
Classification
Class II
Quantity
1 (60mL) syringe, 3 (90mL) syringe, 5 (100mL) syringe, 1 (150mL) syringe
Official record key
drug-enforcement:D-0092-2016

Official wording

Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Code information: t12012014@6, t09182014@28, t09162014@31, t09162014@22, t08292014@6, t08122014@26, t07222014@15, t05262015@13, t01192015@11, t05082015@4, t04202015@13

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility