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Injection Recalled for Incorrect Label

Jolynn Tumolo

An incorrect expiration date on the product label has prompted the recall of 1099 vials of Adrenalin (epinephrine) injection packaged by Henry Schein Inc., according to the February 28, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Adrenalin (epinephrine) injection 1 mg/mL, in 1-mL single dose vials (original NDC 42023-159-25, repackaged NDC 0404-9810-01), from original lot 64103 (Exp. 11/24) and repackaged lot 39747 (Exp. 1/26). The product was packaged by Henry Schein Inc., Bastian, Virginia, and distributed throughout the United States.

Henry Schein Inc. and Glove Club HSI Gloves Inc. voluntarily initiated the recall January 17, 2024. On February 21, 2024, the FDA designated the recall Class II, signaling that use of the affected injection may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Adrenalin injection is a prescription drug indicated for the treatment of anaphylaxis and hypotension associated with septic shock.

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