D-1446-2014 Class I Terminated
FDA drug recall D-1446-2014 was initiated by Shamrock Medical Solutions Group LLC on Sep 27, 2011 and is designated Class I. Reason for recall: Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules The recall status is terminated (terminated Jul 31, 2014). Affected quantity: 89/120 mg tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 30, 2014
- Initiation Date
- Sep 27, 2011
- Termination Date
- Jul 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89/120 mg tablets
Product Description
Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90
Reason for Recall
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Distribution Pattern
Product was shipped to the following states: CO, MA, OH, TX & WY.
Code Information
Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90