Recalls / Class I
Class ID-1446-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90
Why it was recalled
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Recalling firm
- Firm
- Shamrock Medical Solutions Group LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 741 Radio Dr, Lewis Center, Ohio 43035-7134
Distribution
- Quantity
- 89/120 mg tablets
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
Timeline
- Recall initiated
- 2011-09-27
- FDA classified
- 2014-07-23
- Posted by FDA
- 2014-07-30
- Terminated
- 2014-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1446-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.