Recalls / Class III

Class IIID-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]

Affected lot / code info

Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).

Why it was recalled

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

Recalling firm

Firm

AMERICAN HEALTH PACKAGING

Address

2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188

Distribution

Quantity

1285 cartons (cartons of 100 individual unit doses)

Distribution pattern

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.

Timeline

Recall initiated

2018-06-25

FDA classified

2018-07-09

Posted by FDA

2018-07-18

Terminated

2020-04-29

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0915-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.