Why it was recalled
Failed Dissolution Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1284-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 24, 2015
- FDA report date
- Aug 12, 2015
- Quantity
- a) 483 bottles; b) 5,631 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shionogi Inc.
Original FDA data
Every field from FDA enforcement report D-1284-2015, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 71828
- Address
- 5770 Shiloh Rd
- Code information
- Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16
- Postal code
- 30005-8408
- Report date
- Aug 12, 2015
- Product type
- Drugs
- Recall number
- D-1284-2015
- Classification
- Class III
- Recalling firm
- Shionogi Inc.
- Product quantity
- a) 483 bottles; b) 5,631 bottles
- Termination date
- Apr 14, 2016
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 4, 2015