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Recall Observatory FDA recall evidence

Drug product

Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05

D-0288-2016

September 12, 2015

Class II

Product summary

Firm
US Compounding Inc
Event
Event 72179
Status
Terminated
Classification
Class II
Quantity
797 vials
Official record key
drug-enforcement:D-0288-2016

Official wording

Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Code information: Lot Code: 20151305@17 BUD: 9/16/2015, 20151504@18 BUD: 9/16/2015, 20151903@13 BUD: 9/12/2015, 20151903@13 BUD: 9/12/2015, 20152107@3 BUD: 1/16/2016, 20152204@6 BUD: 9/16/2015, 20152403@13 BUD: 9/12/2015, 20152403@21 BUD: 9/16/2015, 20152904@8 BUD: 9/16/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility