Status
Terminated
Drug Enforcement D-1398-2012
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Classification
Class II
Report Date
July 4, 2012
Termination Date
February 7, 2013
Product Information
- 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
- Product quantity
- 7230 bottles
- Reason for recall
- Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- PA
Location & Firm
- Recalling firm
- Shionogi Inc.
- Address
-
5770 Shiloh Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1398-2012
- Event ID
- 62004
- Recall initiation date
- March 8, 2012
- Center classification date
- June 26, 2012
- Code info
- Lot number: 2021956, Exp; 01/2013
- More code info
- —