URGENT!!! DRUG RECALL!!! URGENT!!!

Endo USA, Inc. is voluntarily recalling all lots within expiry for the above item. 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. This recall does not include the approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial. This recall is to the Consumer level. Affected product started shipping October 2023.

Please contact your healthcare provider for any medical related questions.

Information contained in this document was provided by Endo who is coordinating directly with the FDA.