FDA-Drug2013-02-13Class II

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.

Watson Pharmaceuticals
Hazard

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%).

Sold states
Nationwide and Puerto Rico
Affected count
3,040 bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-145-2013

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