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Recall Observatory FDA recall evidence

Drug product

SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/9/9MG/9ML, 9 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0122-2016

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
41 syringes
Official record key
drug-enforcement:D-0122-2016

Official wording

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

Code information: t12052014@8, t11192014@26, t11032014@24, t10142014@27, t09172014@2, t08252014@30, t07302014@12, t07092014@15, t06022015@10, t04302015@22, t03312015@18, t03172015@28, t03092015@38, t02102015@21, 10222014@8, 10012014@16, 05132015@5, 02172015@7, 01052015@9.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility