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Recall Observatory FDA recall evidence

Drug product

Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.

D-0732-2018

April 24, 2018

Class II

Product summary

Firm
Vitalab Pharmacy, Inc
Event
Event 80000
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0732-2018

Official wording

Reason: Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

Code information: Lot #: 03052018@54

Distribution pattern: The recalled product was distributed to patients throughout the United States.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility