Actavis Totowa LLC, a generic drug manufacturer, has announced a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.
The inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy or retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.
According to Actavis press release, the recalled products manufactured at the Little Falls facility are: Amantadine 100mg capsules; Meperidine & Promethazine capsules; Amibid DM ER tablets; Meperidine HCl 100 mg and 50 mg tablets; Amibid DM tablets; Methenamine Mandelate 0.5 g and 1.0 g tablets; Amidrine capsules; Mirtazapine 15 mg, 30 mg, and 45 mg tablets; Amigesic 500 mg caplets and 750 mg caplets; Mirtazapine OD tablets, 15 mg, 30 mg and 45 mg.
This action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. If patients wish to obtain replacement medications and/or prescription, they should contact their health care professional or pharmacist.
Recall letters have been issued to wholesalers and retailers, instructing them to return product to Capital Returns, Milwaukee, WI, the release added.