# FDA recall D-0633-2018

> **AVKARE Inc.** · Class II · drug recall initiated 2018-03-30.

## Product

Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0633-2018
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-30
- **Report date:** 2018-04-25
- **Termination date:** 2020-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0633-2018

## Citation

> AI Analytics. FDA recall D-0633-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0633-2018. Source: US FDA. Licensed CC0.

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