Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, L...
FDA Recall #D-0435-2022 — Class II — December 6, 2021
Product Description
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
Reason for Recall
CGMP Deviations
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20 vials
Distribution
nationwide
Code Information
08-2021-03@8 12-31-2021 & 09-2021-07@10 02-04-2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated