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Recall Observatory FDA recall evidence

Drug product

PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

D-1105-2019

February 21, 2019

Class II

Product summary

Firm
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Event
Event 82278
Status
Terminated
Classification
Class II
Quantity
2 prescriptions, 5ml injection
Official record key
drug-enforcement:D-1105-2019

Official wording

Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Code information: Lot:26112018@68, 13122018@12, distributed between 09-01-2018 to 02-20-2019.

Distribution pattern: Dispensed in Oregon

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls