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Recall Observatory FDA recall evidence

Drug 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.

D-145-2013

December 18, 2012

Class II

Product summary

Firm
Watson Pharmaceuticals
Event
Event 64056
Status
Terminated
Classification
Class II
Quantity
3,040 bottles
Official record key
drug-enforcement:D-145-2013

Official wording

Reason: 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%).

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

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specification