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D-0607-2025Class III
Boothwyn Pharmacy LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Boothwyn Pharmacy LLC
Product type
Drug
Status
Ongoing
Report date
2025-09-10
Distribution
U.S. Nationwide
Firm state
PA
Product quantity
8 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Subpotent Drug
Product description
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Code / lot info
06092025@23 BUD 09/09/2025
Other recalls SPEQ maps to Validation & Qualification
2026-10-21Class IIZydus Pharmaceuticals (USA) Inc2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation2026-10-14Class IICipla USA, Inc.
See all Validation & Qualification recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →