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

FDA recall notice · announced July 4, 2012 · Shionogi

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Notes

Distribution: PA
Lot/code information: Lot number: 2021956, Exp; 01/2013
Quantity: 7230 bottles
Status: Terminated
Products in this recall event:
- 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, F (D-1398-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.