FDA-Drug2018-07-18Class III
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]
AMERICAN HEALTH PACKAGING
Hazard
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Sold states
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.
Affected count
1285 cartons (cartons of 100 individual unit doses)
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
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]
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0915-2018Don't want to check this manually?
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