FDA recall D-0915-2018

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]

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-06-25

Report date

2018-07-18

Termination date

2020-04-29

Voluntary/Mandated

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Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0915-2018