# FDA recall D-1284-2015

> **Shionogi Inc.** · Class III · drug recall initiated 2015-07-24.

## Product

Nisoldipine Extended Release Tablets, 17 mg, packaged as a)  Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH  45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1284-2015
- **Recalling firm:** Shionogi Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-24
- **Report date:** 2015-08-12
- **Termination date:** 2016-04-14

- **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-1284-2015

## Citation

> AI Analytics. FDA recall D-1284-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1284-2015. Source: US FDA. Licensed CC0.

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