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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0124-2016

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
298 pellet
Official record key
drug-enforcement:D-0124-2016

Official wording

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

Code information: 01202015@19, 05192015@3, 07222014@27, 08192014@4, 09042014@5, 09232014@21, 10032014@24, 10092014@12, 12012014@16, t01152015@6, t02232015@23, t03122015@1, t03202015@10, t04232015@11, t05062015@22, t05182015@29, t06012015@12, t06112015@10, t06132014@15, t08112014@30, t12182014@19.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility