Why it was recalled
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Product description
Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
Lot numbers, UPCs & expiration codes
Lot number: 2021956, Exp; 01/2013
Where it was sold
PA
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-1398-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 8, 2012
- FDA report date
- Jul 4, 2012
- Quantity
- 7230 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shionogi Inc.
Original FDA data
Every field from FDA enforcement report D-1398-2012, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 62004
- Address
- 5770 Shiloh Rd
- Code information
- Lot number: 2021956, Exp; 01/2013
- Postal code
- 30005-8408
- Report date
- Jul 4, 2012
- Product type
- Drugs
- Recall number
- D-1398-2012
- Classification
- Class II
- Recalling firm
- Shionogi Inc.
- Product quantity
- 7230 bottles
- Termination date
- Feb 7, 2013
- Reason for recall
- Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
- Distribution pattern
- PA
- Recall initiation date
- Mar 8, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2012