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Recall Observatory FDA recall evidence

Drug product

TRIMIX, injectable Solution, 20MG/1MG/20MCG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0148-2016

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
155 syringes
Official record key
drug-enforcement:D-0148-2016

Official wording

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

Code information: t11242014@14, t10082014@1, t08152014@22, t08042014@31, t07252014@19, t07142015@19, t07102015@24, t07082014@2, t04142015@25, t04062015@16, t02242015@29, 12152014@9, 12032014@4, 11122014@2, 10292014@3, 10012014@15, 09232014@23, 09032014@3, 08132014@1, 06242015@4, 06172015@12, 06102015@5, 05272015@10, 05182015@6, 05132015@9, 05042015@5, 04222015@8, 03112015@4, 02102015@30, 01232015@6, 01072015@5;

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility