Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility
Sarita Thapar, PharmD
354-535-2300 / 840 7476
FOR IMMEDIATE RELEASE -- Morristown, NJ, August 1, 2008 -- Actavis Totowa LLC, a generic drug manufacturer, is announcing 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/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.
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 should wish to obtain replacement medications and/or prescription, they should contact their health care professional or pharmacist. For more information regarding this market action, please visit www.actavis.us/RecallFAQ.
Recall letters have been issued to wholesalers and retailers, instructing them to return product to Capital Returns, Milwaukee, WI.
Actavis Totowa, LLC is a United States subsidiary of Actavis Group hf. This voluntary action is limited only to the Actavis Totowa products manufactured in the Little Falls, NJ facility listed below. Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic LLC, Actavis Mid Atlantic LLC or Actavis products manufactured in other facilities are thus not impacted by this recall
|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|
|Amitex PSE tablets||Multi-ret Folic 500 mg tablets|
|Bellamine S tablets||Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets|
|Betaxolol 10 mg and 20 mg tablets USP||Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets|
|Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets||Naltrexone 50mg tablets|
|Carisoprodol & Aspirin tablets||Oxycodone & Acetaminophen 5/500mg capsules|
|Carisoprodol, Aspirin & Codeine tablets||Oxycodone HCl 5 mg, 15 mg and 30 mg tablets|
|Carisoprodol 350mg tablets||Oxycodone HCl 5 mg capsules|
|Chlordiazepoxide w/ Clidinium Bromide capsules||Pentazocine & Acetaminophen tablets|
|Chlorzoxazone 250mg||Pentazocine & Naloxone tablets|
|Cilostazol tablets 100mg||Phenazopyridine HCl 100 mg and 200 mg tablets|
|Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets||Phendimetrazine Tartrate 35mg tablets|
|Cyclobenzaprine HCL 5 mg and 10 mg||Phentermine HCl 37.5 mg tablets|
|Dexchlorpheniramine Maleate 4 mg and 6 mg tablets||Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules|
|Dipyridamole 25 mg, 50mg, and 75 mg tablets||Prenatal Formula 3 tablets|
|Glyburide 1.5 mg, 3.0 mg and 6.0 mg tablets||Prenatal Plus 27 mg FE tablets|
|Guaifenesin & Codeine Phosphate tablets||Prenatal Rx tablets|
|Guaifenesin & Phenylephrine tablets||Quinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets|
|Guanfacine 1.0 mg and 2.0 mg HCl tablets||Rifampin 300mg capsules|
|Hydrocodone & Homatropine tablets||Sodium FL 0.5 mg and 1.0 mg tablets|
|Hydromorphone HCl tablets||Tizanidine HCl 2 mg and 4 mg tablets|
|Hydroxyzine 10 mg, 25 mg and 50 mg tablets||Trimethobenzamide 300mg capsules|
|Hyoscyamine Sulfate 0.125 mg SL||Trimipramine Maleate 25mg, 50mg, 100mg capsules|
|Hyoscyamine Sulfate 0.375mg SR tablets||Trivita 1 mg FL tablets|
|Hyoscyamine Sulfate 0.125 mg (oral) tablets||Ursodiol capsules, 300mg|
|Isradipine 2.5 mg and 5 mg capsules||Vitacon Forte capsules|
|Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsules||Vitaplex Plus tablets|
|Meclizine Chewable 25 mg tablets||Vitaplex tablets (FC)|
|Meloxicam 7.5 mg and 15 mg tablets||Yohimbine HCl 5.4 mg tablets|
Answers to frequently asked questions regarding this market action can be found on www.actavis.us/RecallFAQ.