D-0915-2018 Class III Terminated
FDA drug recall D-0915-2018 was initiated by AMERICAN HEALTH PACKAGING on Jun 25, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant The recall status is terminated (terminated Apr 29, 2020). Affected quantity: 1285 cartons (cartons of 100 individual unit doses).
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 18, 2018
- Initiation Date
- Jun 25, 2018
- Termination Date
- Apr 29, 2020
- Product Quantity
- 1285 cartons (cartons of 100 individual unit doses)
Product Description
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 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.
Code Information
Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0915-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026