Seroxat
The marketing authorization holder informed its wholesalers in a letter dated April 10, 2014, that GlaxoSmithKline (GSK) had received a warning letter from the FDA (US Food and Drug Administration) with concerns about the release of the active ingredient paroxetine. Batches of the active ingredient produced at GSK's Cork, Ireland facility between July 2011 and February 2012 were found to contain impurities in the solvent used. GSK recognizes these FDA concerns and is now conducting a precautionary recall of all finished product batches of paroxetine produced with the affected active ingredient batches. The replacement is being conducted at the wholesale level, and from a medical and safety perspective, the risk to batches in the marketplace is negligible.
| Name of the medicinal product | 1. Seroxat 20 mg – Filmtabletten 2. Seroxat 2 mg/ml - Suspension zum Einnehmen |
|---|---|
| Marketing authorisation number(s) | 1. 1-19931 2. 1-22309 |
| Marketing authorisation holder | GlaxoSmithKline Pharma GmbH |
| Batch number(s) | 1. 601 2. K003, K004, K005, K007 |
| Classification of the recall | 3 |
| BASG reference number | INS - 640.001 - 1067 |
