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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number: 2021956, Exp; 01/2013
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Shionogi Inc.
- Reason for Recall:
- Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot number: 2021956, Exp; 01/2013
Distribution:
Distributed in: PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1398-2012
Related Recalls
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing