Sedative Recalled

CMC Enterprise Pharmacy has issued a recall for dexmedetomidine 400 mcg in NS 100-mL bags because of a lack of sterility assurance, according to the May 1, 2019, US Food and Drug Administration (FDA) Enforcement Report.

Included in the recall are 5678 bags from the following lots, which were distributed in North Carolina: EA141908 (Exp. 4/14/19), EA171909 (Exp. 4/17/19), EA211906 (Exp. 4/21/19), EA251908 (Exp. 4/25/19), EB041905 (Exp. 5/6/19), EB071907 (Exp. 5/8/19), EB151909 (Exp. 5/16/19), EC041906 (Exp. 6/2/19), EC111907 (Exp. 6/9/19), EC181908 (Exp. 6/16/19), and EC201907 (Exp. 6/18/19).

CMC Enterprise Pharmacy voluntarily issued the recall April 12, 2019. On April 23, 2019, the FDA designated it a Class II recall. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Dexmedetomidine is a sedative used during medical procedures and in intensive care settings.

—Jolynn Tumolo