FDAClass IIFebruary 2, 2022

Dibutyl Squaric Acid recall: CGMP Deviations

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

Why was Dibutyl Squaric Acid recalled?

CGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

09-2021-15@5 12-14-2021 & 10-2021-01@4 12-30-2021

Product
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC…
Recalling firm
Edge Pharma, LLC
Quantity
63 vials
Distribution
nationwide
Recall date
February 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls