FDA Alert; Actavis Totowa-A generic Manufacturer

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

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.