Drug & medication recalls Moderate risk

Phenol 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 Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, V…
Recall number
D-0443-2022
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

Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03

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