Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bot…

Recall date

July 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1284-2015

FDA classification

Class III

Brand / firm

Shionogi Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Failed Dissolution Specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.