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Recall Observatory FDA recall evidence

Drug product

Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

D-1573-2019

July 22, 2019

Class II

Product summary

Firm
Wise Pharmacy
Event
Event 83397
Status
Terminated
Classification
Class II
Quantity
84 vials
Official record key
drug-enforcement:D-1573-2019

Official wording

Reason: Lack of Processing Controls

Code information: Lot #: 6054N; 4796N, Exp 7/16/2019; 7049N, Exp 11/24/2019

Distribution pattern: CO, TX, WY

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls