The Recall Desk
ModerateFDA (Drugs)·D-0443-2022·Announced 2022-02-02

Phenol Topical Solution recalled for CGMP manufacturing deviations

Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

What this means for you

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: The FDA classified this as Class II. The source text does not report any illnesses, injuries, or adverse events. The recall is based on theoretical manufacturing compliance deviations without evidence of actual harm. This meets the criteria for Moderate severity.

Plain-English summary

Edge Pharma, LLC is voluntarily recalling Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial (NDC 05446-1211-03) manufactured at 856 Hercules Drive, Colchester, Vermont. The recall involves 1,861 jars distributed nationwide and was initiated on December 6, 2021.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The FDA classified this as a Class II recall on January 24, 2022, and the recall was publicly announced via press release on February 2, 2022.

Affected lot codes and date ranges are: 07-2021-12@9 (07/22/21–08/11/21); 08-2021-11@10 (08/25/21–09/10/21); 08-2021-12@12 (09/07/21–10/06/21); 09-2021-22@5 (10/12/21–10/28/21); 10-2021-07@8 (10/25/21–10/28/21); 10-2021-08@4 (10/28/21–11/12/21); and 11-2021-01@7 (11/15/21–12/01/21). Consumers or healthcare providers with this product should contact Edge Pharma, LLC for instructions on return or disposal. The recall was terminated on June 7, 2023.

The recalled product

Product
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
Manufacturer
Edge Pharma, LLC
Category
Drug — Topical Solution
Hazard
  • cgmp-deviation
  • manufacturing-quality

Distribution

Distributed nationwide across the United States.

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