Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0435-2022·Announced 2022-02-02

Dibutyl Squaric Acid Topical Solution Recalled Due to CGMP Deviations

Edge Pharma, LLC is recalling 20 vials of Dibutyl Squaric Acid topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The drug was distributed in multiple dose vials containing 1%, 10 mL each.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving CGMP deviations in a drug product. The source text does not report any illnesses, injuries, or hospitalizations. The recall is classified as voluntary and precautionary in nature, warranting a Moderate severity level consistent with Class II recalls without reported adverse health events.

Plain-English summary

Edge Pharma, LLC is voluntarily recalling Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial (NDC 05446-1156-03) nationwide. A total of 20 vials are affected by this recall.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The affected product has lot codes 08-2021-03@8 with an expiration date of 12-31-2021 and 09-2021-07@10 with an expiration date of 02-04-2022.

The U.S. Food and Drug Administration classified this as a Class II recall. Consumers in possession of affected vials should contact their healthcare provider or pharmacist for guidance. The recall was initiated on December 6, 2021, and has been terminated as of June 7, 2023.

The recalled product

Product: 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
Manufacturer: Edge Pharma, LLC
Category: Drug — Topical Solution
Hazard: cgmp-deviation
manufacturing-defect
Affected units: 20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

08-2021-03@8 12-31-2021 & 09-2021-07@10 02-04-2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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