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Recall Observatory FDA recall evidence

Drug product

ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0085-2016

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
68 pellets
Official record key
drug-enforcement:D-0085-2016

Official wording

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

Code information: t12092014@19, t11252014@18, t09222014@34, t09082014@23, t09052014@11, t08262014@16, t08042014@36, t07022015@34, t06022015@28, t05112015@13, t03302015@22, t03062015@27, t01232015@23, t01022015@16, 10242014@3, 10072014@5.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility