EPI Health, LLC Issues Voluntary Recall
April 23 2024 - 11:34AM
Business Wire
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 ppsi7150@sedgwick.com.
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
Product
NDC
Lot Numbers/
Expiry Date
Indication
Cloderm
(Clocortolone Pivalate)
0.1%
45g Tube- Cream
RX Only
71403-0804-45
SDFC- 5/31/2024
TFBW- 5/31/2025
Dermatomyositis
Minolira
(Minocycline) ER 105mg
30 count Botle Oral Tablet
RX Only
71403-0101-30
T2300765- 11/30/2025
T2201702A-02/28/2025
T2201699- 2/28/2025
T2201698- 2/28/2025
Non-nodular moderate to severe acne
vulgaris
Minolira
(Minocycline) ER 135mg
30 count Botle Oral Tablet
RX Only
71403-102-30
T2201700- 02/28/2025
T2201701- 02/28/2025
Non-nodular moderate to severe acne
vulgaris
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EPI Health recall Customer Service 1-888-671-8858