AMERICAN HEALTH PACKAGING recalls Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distri
Recalled July 18, 2018 · FDA recall D-0915-2018 · AMERICAN HEALTH PACKAGING
Hazard
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant · FDA Class III
Units
1285 cartons (cartons of 100 individual unit doses)
Sold at
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.
Description
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Product
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]
Manufacturer(s)
AMERICAN HEALTH PACKAGING
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →