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Recall Observatory FDA recall evidence

Drug product

Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

D-1070-2015

March 17, 2015

Class II

Product summary

Firm
Fallon Wellness Pharmacy, L.L.C.
Event
Event 70807
Status
Terminated
Classification
Class II
Quantity
8 vials
Official record key
drug-enforcement:D-1070-2015

Official wording

Reason: Lack of assurance of sterility

Code information: Lot #: a) 11172014@75- Exp 4/12/2015

Distribution pattern: New York

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility