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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE, Pellet, 112 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0128-2016

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
91 pellets
Official record key
drug-enforcement:D-0128-2016

Official wording

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

Code information: t12192014@18, t12092014@37, t11252014@6, t11192014@25, t10212014@24, t10172014@18, t09252014@14, t07162015@28, t07152014@12, t07062015@13, t06042015@18, t05282015@27, t04242015@23, t03192015@35, t02242015@23, t02192015@15, t02062015@9, t01292015@27, 11052014@20, 04102015@9.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility