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Recall Observatory FDA recall evidence

Drug product

Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

D-1006-2020

February 24, 2020

Class II

Product summary

Firm
Redline Pharmacy Solutions
Event
Event 85081
Status
Terminated
Classification
Class II
Quantity
2x5 ml bottles
Official record key
drug-enforcement:D-1006-2020

Official wording

Reason: Lack Of Processing Controls

Code information: Lot 02242020@1

Distribution pattern: Sold to patients in Nebraska

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack Of Processing Controls