FDA (Drugs) recall action 68967
The FDA (Drugs) publishes a recall like this one as 9 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 9 pages.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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 Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Apotex Inc. is recalling PAXIL (Paroxetine HCL) 10 mg tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Apotex Inc. is recalling PAXIL (Paroxetine HCL) 40 mg tablets due to contamination with residual materials and solvents.
Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets 25 mg because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.
Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Apotex Inc. is recalling PAXIL (Paroxetine HCL) Oral Suspension because it was manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Apotex Inc. is recalling specific lots of PAXIL (Paroxetine HCL) 20 mg tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.
Apotex Inc. is recalling specific lots of Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.