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Recall Observatory FDA recall evidence

Drug product

PROGESTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0116-2016

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
21 pellets
Official record key
drug-enforcement:D-0116-2016

Official wording

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

Code information: t12292014@29, t11262014@15, t11202014@25, t11202014@10, t08292014@26, t07072015@20, t06222015@10, t06162015@16, t06012015@10, t05292014@20, t04302015@13, t04162015@8, t03102015@3, t02062015@13, t01062015@20.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility