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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0131-2016

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
20 pellets
Official record key
drug-enforcement:D-0131-2016

Official wording

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

Code information: t12052014@18, t11252014@19, t11192014@18, t11112014@4, t09192014@18, t09102014@20, t08272014@10, t06242015@30, t06022015@8, t05202015@11, t05042015@22, t05012015@17, t04102015@4, t03302015@21, t03202015@18, t03052015@12, t02252015@10, t01302015@23, t01232015@24, t01142015@21.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility