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Epinephrine Injection Recalled


July 27, 2018

Avella of Deer Valley Inc. is recalling single-dose bags of epinephrine because of the potential for leakage, according to the July 25, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 2 formulations:

  • epinephrine 4 mg, 5% dextrose 250 mL, 254-mL single-dose bags (NDC 15082-855-25) from lots 5/4/18 0300 58-85525P (BUD 6/18/18), 5/10/18 1435 262-85525P and 5/10/18 1127 558-85525P (BUD 6/24/18), 5/11/18 1327 457-85525P (BUD 6/25/18), 5/14/18 0302 295-85525P (BUD 6/28/18), 5/17/18 0500 558-85525P (BUD 7/1/18), 5/24/18 1005 57-85525P and 5/24/18 1328 295-85525P (BUD 7/7/18), 5/25/18 0302 295-85525P (BUD 7/9/18), 5/30/18 0936 262-85525P (BUD 7/14/18), and 5/31/18 0805 558-85525P (BUD 7/17/2018); and
  • epinephrine 4 mg, 0.9% sodium chloride 250 mL, 254-mL single-dose bags (NDC 42852-823-25) from lots 4/30/18 0512 2-82325P (BUD 6/14/18) and 5/22/18 1238 82325P (BUD 7/6/18).

The bags were distributed throughout the United States.

Avella of Deer Valley voluntarily initiated the recall June 12, 2018. The FDA designated the recall Class II July 19, 2018. The designation signals use of the bags could cause a temporary health problem, with a remote possibility of serious harm.

Epinephrine is a sympathomimetic drug most commonly used to ease distress from bronchospasm, provide quick relief of hypersensitivity reactions to allergens, and to prolong the action of infiltration anesthetics.

Jolynn Tumolo


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