Surgical Hypotension Drug Recalled

Avella of Deer Valley Inc. is recalling phenylephrine 25 mg and phenylephrine 30 mg added to NS 250-mL bags because of a lack of assurance of sterility, according to the November 7, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 300 bags of phenylephrine 25 mg from lot 138-20182308@88 (Exp. 11/6/18) and 300 bags of phenylephrine 30 mg from lot 138-20180409@55 (Exp. 11/18/18). The affected bags were distributed across the United States.

Avella of Deer Valley Inc. voluntarily initiated the recall October 19, 2018. On November 1, 2018, the FDA designated the recall Class II. Use of drugs affected by Class II recalls could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Phenylephrine injection is used to treat low blood pressure that occurs during surgery.

—Jolynn Tumolo

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