FDA (Drugs) recall action 96209
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
CGMP Deviations
The agency’s own wording, quoted from the enforcement report.
Aspen Biopharma Labs is voluntarily recalling Chlorambucil due to manufacturing process deviations. The product was distributed to distributors in Hong Kong and Florida.
Aspen Biopharma Labs is recalling finasteride due to manufacturing compliance deviations. The 120 kg voluntary recall was distributed to three distributors in Hong Kong and Florida.
Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).
Aspen Biopharma Labs is recalling Bimatoprost due to manufacturing practice deviations. The recall is voluntary and affects product distributed to wholesalers.
Aspen Biopharma Labs is recalling Latanoprost medication due to manufacturing practice deviations. The voluntary recall affects product distributed to distributors in Hong Kong and Florida.
Aspen Biopharma Labs is voluntarily recalling Voriconazole, an antifungal medication, due to manufacturing process deviations. The product was distributed to three distributors in Hong Kong and Florida.