Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
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 Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
Compare with the code on your package — it is the most precise check available.
Drug: Doxazosin
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.
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
Lack of Assurance of Sterility
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
cGMP Deviations
Failed Impurities/Degradation Specifications - at 18-month Stability testing
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