Status
Terminated
Drug Enforcement D-145-2013
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%).
Classification
Class II
Report Date
February 13, 2013
Termination Date
July 30, 2014
Product Information
- 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.
- Product quantity
- 3,040 bottles
- 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%).
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Watson Pharmaceuticals
- Address
-
400 Interpace Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-145-2013
- Event ID
- 64056
- Recall initiation date
- December 18, 2012
- Center classification date
- February 4, 2013
- Code info
- Lot #: 512146A, Exp 01/31/2014
- More code info
- —