June 2018 FDA Recall Drug by American Health Packaging
D-0915-2018 - Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant

This Class III drug recall was initiated by American Health Packaging on June 25, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification; out-of-specification results for the enalapril dkt degradant. The product was distributed in 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. and the recall is currently terminated.

Recall Number: D-0915-2018

Reason for Recall
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Initiated
06-25-2018
Reported
07-18-2018
Quantity
1285 cartons (cartons of 100 individual unit doses)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80389
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AMERICAN HEALTH PACKAGING
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial 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.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-29-2020
Product Description About Product Description
Full technical description of the 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]

Batch or Lot Expiration Information

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