Reported Aug 12, 2015 · Terminated
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count…
Shionogi Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shionogi Inc. · 5770 Shiloh Rd · Alpharetta, GA · 30005-8408
Is this the product you have?
- 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 forShionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4)
- Manufactured forPrasco Laboratories, Mason, OH 45040; Rx only
- Manufactured byAenova France SAS, 38291 Saint Quentin-Falavier, France
- Lot codes and dates
Lot #: a) 8803472Exp 03/16b) 8803473Exp 03/16
- Amount recalled
- a) 483 bottles; b) 5,631 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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