Recalls / Class III
Class IIID-1284-2015
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.
- Brand name
- Nisoldipine
- Generic name
- Nisoldipine
- Active ingredient
- Nisoldipine
- Route
- Oral
- NDCs
- 66993-472, 66993-473, 66993-475
- FDA application
- NDA020356
- Affected lot / code info
- Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Shionogi Inc.
- Manufacturer
- Prasco Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5770 Shiloh Rd, N/A, Alpharetta, Georgia 30005-8408
Distribution
- Quantity
- a) 483 bottles; b) 5,631 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-07-24
- FDA classified
- 2015-08-04
- Posted by FDA
- 2015-08-12
- Terminated
- 2016-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1284-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.