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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE, Pellet, 76 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0138-2016

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
18 pellets
Official record key
drug-enforcement:D-0138-2016

Official wording

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

Code information: t12172014@7, t12092014@16, t10062014@26, t08252014@4, t05292015@3, t05212015@18, t05052014@11, t04012015@1, t01202015@15, t01052015@30.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility