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
Reported: July 4, 2012 Initiated: March 8, 2012 #D-1398-2012
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
Reason for Recall
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Details
- Recalling Firm
- Shionogi Inc.
- Units Affected
- 7230 bottles
- Distribution
- PA
- Location
- Alpharetta, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Shionogi Inc.. Units affected: 7230 bottles.
Why was this product recalled? ▼
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 4, 2012. Severity: Moderate. Recall number: D-1398-2012.
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