Par Pharmaceutical Adrenalin® Chloride Solution recalled due to an unapproved drug, USA

United States

Endo USA, Inc., is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. This product, which pre-dates the 1938 Federal Food, Drug & Cosmetic Act, was never submitted for approval by the FDA, and as such, is an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. In addition, FDA has determined the product to be misbranded with a misleading label similar in appearance to the FDA-approved drug product Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial, also produced by Endo USA, Inc. The product lots being recalled were distributed nationwide in the United States to wholesale distributors from October 10, 2023, through December 11, 2024.

Both products are distributed to hospitals and healthcare systems for use by healthcare professionals. The similarity in labeling makes it difficult to distinguish between the non-sterile topical and sterile injectable product which can lead to potential administration errors. This recall does not include the approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial.

Risk Statement: Intravenous administration of the unapproved non-sterile topical Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP), instead of the approved sterile Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial for injection, would result in non-fatal serious and/or severe, health outcomes related to delayed or inadequate treatment of the underlying condition (anaphylaxis, hemodynamic instability, hypotension) or infection due to intravenous administration of a non-sterile product.

In addition, there is a high probability that intravenous administration of the nasal product will result in patients receiving the wrong dose of epinephrine in emergency situations for serious, life-threatening conditions such as the treatment of anaphylaxis, blood pressure support, and cardiac arrest. If these events are not treated with the correct dose of epinephrine, patients may be at risk for death.

This recall impacts the following:
- Product: Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) for topical application
- Size: 30mg/30mL (1mg/mL)
- NDC: 42023-103-01
- Lot # 82809 (Date of Expiry of 03/2026)
- Lot # 79637 (Date of Expiry of 11/2025)
- Lot # 77776 (Date of Expiry of 07/2025)
- Lot # 74716 (Date of Expiry of 05/2025)
- Lot # 71835 (Date of Expiry of 01/2025)
- Lot # 72916 (Date of Expiry of 01/2025)

Wholesale distributors that have the product lots being recalled should immediately discontinue use and stop distribution immediately.

Company name: Endo, Inc.
Brand name: Par Pharmaceutical
Product recalled: Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP)
Reason of the recall: The product is an unapproved drug.
FDA Recall date: December 20, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal