Medicine recalls
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| The United States: Endo USA, Inc. issues voluntary, nationwide recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) due to the potential for administration errors |
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The United States Food and Drug Administration (FDA) announces that 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.
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.
Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) is a vasoconstrictor for topical application. The 30 mL vial is distributed in individually packed cartons under NDC #42023-103-01 with the language “Nasal Solution USP” and “For Topical Application” on the package. The product lots being recalled (lot number: 82809, 79637, 77776, 74716, 71835, 72916) were distributed nationwide to wholesale distributors from October 10, 2023, through December 11, 2024.
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.
Endo has not received reports of adverse events in the last five years.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, 21 Dec, 2024
Issued at HKT 12:00
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