EPI Health, LLC Issues Voluntary Recall

EPI Health, LLC (Novan) has filed Chapter 7 bankruptcy on July 17, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The EPI Health/Novan Trustee is initiating a voluntary recall of various within-expiry human drug products (Attachment 1) as a result of the closures and discontinuation of the post-marketing quality, regulatory and pharmacovigilance activities for these marketed products. The discontinuation of these post-marketing programs means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.

Risk Statement: The discontinuation of the post-marketing programs would result in the company's inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. EPI Health has not received any reports of adverse events related to this recall.

The affected products are listed in Attachment I (human drugs) of this release. Only products and lot numbers listed in the attachments are affected by the recall. Products lot numbers not included are owned and distributed by a new product ownership and are continuing to be monitored under a Quality Program and will remain on the market.

EPI Health, LLC is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. EPI Health is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.

Consumers with questions regarding this recall can contact EPI Health at Phone: 888-671-8858 during normal business hours (8am ? 5pm CDT) Monday ? Friday or thru email at [email protected]. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

? _Complete and submit the report Online: www.fda.gov/medwatch/report.htm

? _Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

ATTACHMENT 1
LIST AND LOT NUMBERS OF AFFECTED PRODUCTS