Heart Drug Recalled

Baxter Healthcare Corporation is recalling more than 400,000 vials of metoprolol tartrate injection, USP, 5 mg/5 mL (1 mg/mL), because samples failed to meet pH specifications, according to the November 14, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The FDA reported an “upward shift in the pH of the solution within the shelf life of the impacted lots.”

The recall affects single-use glass vials of metoprolol tartrate (NDC 36000-033-10), manufactured for Claris Lifesciences by Claris Injectables, from the following lots:

• A061267 and A061273 (Exp. 10/18);
• A061392, A061395, A061398, A061403, and A061407 (Exp. 11/18);
• A0A0070, A0A0073, A0A0079, A0A0081, and A0A0083 (Exp. 12/18);
• A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, and A0A0152 (Exp. 1/19);
• A0A0247, A0A0252, A0A0253, A0A0292, and A0A0293 (Exp. 2/19);
• A0A0361, A0A0367, and A0A0390 (Exp. 3/19);
• A0A0438, A0A0445, A0A0453, and A0A0459 (Exp. 4/19);
• A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, and A0A0638 (Exp. 5/19);
• A0A0777 (Exp. 7/19);
• A0A0915, A0A0919, A0A0924, and A0A0930 (Exp. 8/19); and
• A0A1094, A0A1097, A0A1110, (Exp. 11/19).

The affected vials were distributed throughout the United States and in Puerto Rico.

Baxter Healthcare Corporation voluntarily initiated the recall October 15, 2018. On November 7, 2018, the FDA designated the recall Class III, signaling use of the recalled vials is not likely to cause adverse health consequences.

Metoprolol tartrate injection is a prescription beta-blocker used for the treatment of hypertension.

—Jolynn Tumolo

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