Drug & medication recalls Moderate risk

Dibutyl Squaric Acid recalled over manufacturing violations

Recall date
December 6, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Edge Pharma, LLC recalls Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr.,…
Recall number
D-0435-2022
FDA classification
Class II
Brand / firm
Edge Pharma, LLC
Sold / distributed
nationwide

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03

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