ACE Inhibitor Recalled

Enalapril maleate tablets are being recalled by 2 US-based pharmaceutical companies after a manufacturing firm announced out-of-specification degradation results for the drug’s enalapril diketopiperazine component. The recalls were announced in the August 1, 2018, US Food and Drug Administration (FDA) Enforcement Report.

Prompted by a recall from Wockhardt, Major Pharmaceuticals issued a sub-recall for the following enalapril maleate products, which were distributed in the United States and Puerto Rico:

• enalapril maleate tablets, USP, 5 mg, 100 tablets (10 x 10) unit dose per carton (NDC 0904-5502-61), from lots T-01082 (Exp. 8/18), DR10445A (Exp. 9/18), DR10443A (Exp. 12/18), DR10445B (Exp. 3/19), DR10725A (Exp. 7/19), and DS10024A and DS10040A (Exp. 10/19); and
• enalapril maleate tablets, USP, 2.5 mg, 100 tablets (10 x 10) unit dose per carton (NDC 0904-5609-61), from lots T-01083 (Exp. 8/18), DR10447A (Exp. 9/18), DS10201A (Exp. 7/19), DS10201B and DS10201C (Exp 8/19), and DS10319A (Exp. 10/19).

In addition, Aidarex Pharmaceuticals is recalling the following products, which were distributed throughout the United States:

• enalapril maleate, USP, 5 mg, 30-count bottle (NDC 33261-0693-30), from lots 51904-2 (Exp. 1/31/18), 51904-3 (Exp. 2/28/18), 51904-5 (Exp. 3/31/18), 52885-2 (Exp. 3/31/18), and 53840-1 (Exp. 5/28/18);
• enalapril maleate, USP, 5 mg, 90-count bottle (NDC 33261-0693-90), from lots 51904-1 (Exp. 1/31/18), 51904-4 and 52885-1 (Exp. 3/31/18), 52885-3 (Exp. 4/30/18), 52885-4, (Exp. 5/28/18), 53840-2 (Exp. 5/28/18), 53840-3 (Exp. 6/30/18), 53840-4 (Exp. 8/31/18), 56665-1 (Exp. 1/31/19), and 58596-1 (Exp. 5/28/19); and
• enalapril maleate, USP, 2.5 mg, 90-count bottle (NDC 33261-0977-90), from lots 56698-1 (Exp. 1/31/19) and 56698-2 (Exp. 4/30/19).

The Major Pharmaceuticals and Aidarex Pharmaceuticals recalls were voluntarily initiated at the end of June and were designated Class III by the FDA a month later. A Class III categorization signals use of the affected drug is not likely to cause harm.

Enalapril maleate is a prescription ACE inhibitor used to treat high blood pressure and heart failure. It can also prevent heart failure in patients with left ventricular dysfunction.

—Jolynn Tumolo

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