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Recall Observatory FDA recall evidence

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

D-1446-2014

September 27, 2011

Class I

Product summary

Firm
Shamrock Medical Solutions Group LLC
Event
Event 64611
Status
Terminated
Classification
Class I
Quantity
89/120 mg tablets
Official record key
drug-enforcement:D-1446-2014

Official wording

Reason: Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules

Code information: Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix Up

Field note

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