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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