# FDA recall D-0854-2020

> **American Health Packaging** · Class II · drug recall initiated 2019-12-04.

## Product

Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.  NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11

## Reason for recall

Failed Dissolution Specifications: Low out of specification results obtained during stability testing.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0854-2020
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-04
- **Report date:** 2020-02-19
- **Termination date:** 2022-08-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2020

## Citation

> AI Analytics. FDA recall D-0854-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0854-2020. Source: US FDA. Licensed CC0.

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