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.
D-1284-2015
Product summary
- Firm
- Shionogi Inc.
- Event
- Event 71828
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 483 bottles; b) 5,631 bottles
- Official record key
drug-enforcement:D-1284-2015
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications