FDAClass IIJuly 4, 2012

Nisoldipine Extended Release Tablets recall: Failed Dissolution

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by…

Why was Nisoldipine Extended Release Tablets recalled?

Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: 2021956, Exp; 01/2013

Product
Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by…
Recalling firm
Shionogi Inc.
Quantity
7230 bottles
Distribution
PA
Recall date
July 4, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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