Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
Reason CGMP Deviations
Taztia XT
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
What was recalled
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
- Recalling firm
- Shamrock Medical Solutions Group LLC
- NDC code
- 62037-0696-90
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1446-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Diltiazem recalls
See all
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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