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Recall Observatory FDA recall evidence

Drug product

TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258

D-0160-2016

October 06, 2015

Class II

Product summary

Firm
Chen Shwezin, Inc. dba Park Compounding Pharmacy
Event
Event 72402
Status
Terminated
Classification
Class II
Quantity
2 vials
Official record key
drug-enforcement:D-0160-2016

Official wording

Reason: Lack of Assurance of Sterility: all sterile compounded products within expiry

Code information: Lot# 09162015@4, Exp, 10/16/15

Distribution pattern: CA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility