Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Compare with the code on your package — it is the most precise check available.
Drug: Doxazosin
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Doxazosin NDC 70518-1560 |
MESYLATE 2 mg/1 | Tablet Oral |
Remedyrepack INC. | Rx |
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.
Tablets/Capsules Imprinted with Wrong ID
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
CGMP Deviations
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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