Drug recall D-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.
Reason for recall
Failed Dissolution Specifications
Lots and codes
Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16
Recall details
- Recalling firm
- Shionogi Inc., Alpharetta, GA
- Quantity
- a) 483 bottles; b) 5,631 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 24, 2015
- Terminated
- April 14, 2016
Related products
- Nisoldipine – drug information
- NDC 66993-473 Nisoldipine · Nisoldipine 17 mg/1 · Prasco Laboratories
- NDC 66993-472 Nisoldipine · Nisoldipine 8.5 mg/1 · Prasco Laboratories
- NDC 66993-475 Nisoldipine · Nisoldipine 34 mg/1 · Prasco Laboratories