Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations
Taztia XT
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
Affected NDC
62037-0700-90
Compare with the code on your package — it is the most precise check available.
Drug: Diltiazem
- Recalling firm
- Watson Pharmaceuticals
- NDC code
- 62037-700-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-145-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Diltiazem recalls
See all
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Other dissolution failure recalls from 2012
All dissolution failure recalls
Class II · Moderate risk
Isoniazid Tablets 300 mg tablets USP
Failed Dissolution Specifications; 36 month stability timepoint
Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
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