FDA recall D-1446-2014

Shamrock Medical Solutions Group LLC · Class I · drug

Product

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

Product was shipped to the following states: CO, MA, OH, TX & WY.

Key facts

Status: Terminated
Initiation date: 2011-09-27
Report date: 2014-07-30
Termination date: 2014-07-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lewis Center, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1446-2014