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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE, Pellet, 125 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0132-2016

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
355 pellets
Official record key
drug-enforcement:D-0132-2016

Official wording

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

Code information: 01052015@21, 01162015@21, 02122015@8, 03252015@14, 04022015@14, 04102015@8, 04172015@30, 05192015@8, 06162014@12, 07102015@6, 07222014@18, 08072014@3, 08192014@5, 09022014@36, 09102014@26, 09192014@19, 10032014@25, 10092014@11, 10282014@1, 10312014@8, 11122014@27, 12032014@13, t03042015@9, t06022015@13, t06272014@20.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility