Endo Recalls Adrenalin Chloride Solution

In a press release posted on FDA’s website on Dec. 20, 2024, Endo USA, Inc. announced it was voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials. The recall was issued because the product, which is a vasoconstrictor for topical application that predates the 1938 Federal Food, Drug & Cosmetic Act, was never approved by FDA. The product was also found to be misbranded by FDA with a misleading label that is similar to one for an FDA-approved drug, Adrenalin (epinephrine injection, USP) (1 mg/mL) 30 mL vial, which is also produced by Endo. The approved Adrenalin (epinephrine injection, USP) (1 mg/mL) 30 mL vial has not been recalled.

According to FDA, the labeling similarity makes telling the difference between the non-sterile topical product and the sterile injectable product difficult. This could lead to administration errors.

“Intravenous administration of the unapproved non-sterile topical Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP), instead of the approved sterile Adrenalin (epinephrine injection, USP) (1 mg/mL) 30 mL 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,” the press release stated (1). “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.”

The recalled lots are packaged as 30 mL vials in individually packed cartons under national drug code number (NDC) #42023-103-01 that say, “Nasal Solution USP” and “For Topical Application” on the package. The following lots of Adrenalin Chloride Solution (EPINEPHrine Nasal Solution, USP) for topical application 30 mg/30 mL (1 mg/mL), which were distributed nationwide from Oct. 10, 2023 through Dec. 11, 2024, are recalled:

• NDC 42023-103-01. Lot 82809. Expiry date: 03/2026
• NDC 42023-103-01. Lot 79637. Expiry date: 11/2025
• NDC 42023-103-01. Lot 77776. Expiry date: 07/2025
• NDC 42023-103-01. Lot 74716. Expiry date: 05/2025
• NDC 42023-103-01. Lot 71835. Expiry date: 01/2025
• NDC 42023-103-01. Lot 72916. Expiry date: 01/2025.

Notification is being provided by the company to direct consumer accounts. Wholesalers are advised to discontinue the recalled lots immediately. Endo states in the press release that the company has not reported adverse events associated with the product in the past five years. Adverse reactions may be reported to FDA through its MedWatch Adverse Event Reporting program.

This is not the first recall for Endo in 2024. In July, the company recalled one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets (also seen as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 mg tablets 60-count) because an incorrect strength appeared on the cartons of some packs (2). The product strength was listed as 0.125 mg and not 0.25 mg. The inside blister strips, however, had the correct strength of 0.25 mg noted. The error was made by a third-party packager.

References

1. FDA.Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors. Press Release. Dec. 20, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal
2. FDA. Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton. Press Release, July 17, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp