FDA (Drugs) recall action 93353
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.
Apotex Corp. is recalling Paroxetine 10 mg tablets nationwide due to out-of-specification impurities in an excipient. Affected lots expire 08/2024.
Apotex Corp. is recalling Paroxetine Hydrochloride 20 mg tablets nationwide due to out-of-specification impurity levels in affected lots. No illnesses have been reported.
Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.