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Recall Observatory FDA recall evidence

Drug product

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

D-0607-2025

July 09, 2025

Class III

Product summary

Firm
Boothwyn Pharmacy LLC
Event
Event 97202
Status
Ongoing
Classification
Class III
Quantity
8 vials
Official record key
drug-enforcement:D-0607-2025

Official wording

Reason: Subpotent Drug

Code information: 06092025@23 BUD 09/09/2025

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent