Nisoldipine Extended Release Tablets…

Date

Aug. 12, 2015

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Shionogi Inc.

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

Failed Dissolution Specifications

Distribution pattern

Nationwide and Puerto Rico

Quantity

a) 483 bottles; b) 5,631 bottles

Codes and lots

Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16

Recall started

July 24, 2015

Recall number

D-1284-2015

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1284-2015. The agency record governs; check it and the company before acting.