Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

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02 AUG 2008 / Product

Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

Morristown, NJ, 1 August, 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

http://www.actavis.us/en/media+center/newsroom/articles/RecallFAQ.htm

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

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
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

Inquiries
Actavis, Inc.
Medical Affairs
Tel. 908-659-2894

Media Inquiries
Actavis Group
Hjordis Arnadottir
Director - External Communications
Tel: (+354) 535 2300 / 840 7476
E-mail: Harnadottir@actavis.com

Press releases

Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

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