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Recall Observatory FDA recall evidence

Drug product

TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0151-2016

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
10 syringes
Official record key
drug-enforcement:D-0151-2016

Official wording

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

Code information: t12102014@2, t11212014@14, t11102014@22, t11072014@10, t10102014@20, t08072014@37, t06222015@13, t06192015@27, t06112015@23, t04142015@9, t02272015@26.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility