FDA recall D-1284-2015

Shionogi Inc. · Class III · drug

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1284-2015