Class III
Terminated
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.
- Company
- Shionogi Inc.
- Recall Initiated
- July 24, 2015
- Posted
- August 12, 2015
- Recall Number
- D-1284-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 483 bottles; b) 5,631 bottles
- Firm Location
- Alpharetta, GA, United States
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16
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