FDAClass IIFebruary 13, 2013

Taztia XT(diltiazem HCI extended release capsules recall: Failed Dissolution

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.

Why was Taztia XT(diltiazem HCI extended release capsules recalled?

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%).

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 #: 512146A, Exp 01/31/2014

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.
Recalling firm
Watson Pharmaceuticals
Quantity
3,040 bottles
Distribution
Nationwide and Puerto Rico
Recall date
February 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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