Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower…
Reason Tablets/Capsules Imprinted with Wrong ID
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30
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.
Reason Tablets/Capsules Imprinted with Wrong ID
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
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