# FDA recall D-0915-2018

> **AMERICAN HEALTH PACKAGING** · Class III · drug recall initiated 2018-06-25.

## 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

- **Recall number:** D-0915-2018
- **Recalling firm:** AMERICAN HEALTH PACKAGING
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-25
- **Report date:** 2018-07-18
- **Termination date:** 2020-04-29

- **Voluntary/Mandated:** —
- **Location:** Columbus, OH, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall D-0915-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0915-2018. Source: US FDA. Licensed CC0.

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