Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules pe...
FDA Recall #D-145-2013 — Class II — December 18, 2012
Product Description
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
Reason for Recall
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Recalling Firm
Watson Pharmaceuticals — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,040 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 512146A, Exp 01/31/2014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated