PlainRecalls
FDA Drug Moderate Class II Terminated

Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03

Reported: February 2, 2022 Initiated: December 6, 2021 #D-0434-2022

Product Description

Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03

Reason for Recall

CGMP Deviations

Details

Recalling Firm
Edge Pharma, LLC
Units Affected
63 vials
Distribution
nationwide
Location
Colchester, VT

Frequently Asked Questions

What product was recalled?
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03. Recalled by Edge Pharma, LLC. Units affected: 63 vials.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0434-2022.