December 2012 FDA Recall Drug by Watson Pharmaceuticals
D-145-2013 - Failed Dissolution Specification

This Class II drug recall was voluntarily initiated by Watson Pharmaceuticals on December 18, 2012 for the product Drug. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-145-2013

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%).
Initiated
12-18-2012
Reported
02-13-2013
Quantity
3,040 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64056
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Watson Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 512146A, Exp 01/31/2014