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Recall Observatory FDA recall evidence

Drug product

DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

D-1087-2019

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
12 prescriptions
Official record key
drug-enforcement:D-1087-2019

Official wording

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

Code information: Lots: 23012019@48, 24012019@2, 24012019@36, 28012019@35, 29012019@13, 05022019@5, 11022019@13, 12022019@20, 19022019@1, 19022019@6, 19022019@57, 19022019@61, All lots within expiry 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