# FDA recall D-1398-2012

> **Shionogi Inc.** · Class II · drug recall initiated 2012-03-08.

## Product

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only,  Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01

## Reason for recall

Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point

## Distribution

PA

## Key facts

- **Recall number:** D-1398-2012
- **Recalling firm:** Shionogi Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-03-08
- **Report date:** 2012-07-04
- **Termination date:** 2013-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1398-2012

## Citation

> AI Analytics. FDA recall D-1398-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1398-2012. Source: US FDA. Licensed CC0.

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