AMERICAN HEALTH PACKAGING recalls Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distr…

Recall date

June 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0915-2018

FDA classification

Class III

Brand / firm

AMERICAN HEALTH PACKAGING

Sold / distributed

Lot#166023 products distributed from 12/29/16 to 1/19/17 and Lot#168467 distributed from 4/6/17 to 9/11/17. Distributors are the wholesalers who received the product; others are the Corporate Offices for those wholesalers.

Why it was recalled

Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]