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

Filed August 5th, 2008 amy

Actavis Totowa LLC, a generic drug manufacturer, is announcing a to the retail level, which includes wholesalers and hospitals, of all drug products manufactured at its Little Falls, New Jersey facility. This recall follows an inspection conducted by the Food and Drug Administration earlier this year which revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices.

This recall affects the following medications:

Amantadine 100mg capsules, Amibid DM ER tablets, Amibid DM tablets, Amidrine capsules, Amigesic 500 mg caplets and 750 mg caplets, Amitex PSE tablets, Bellamine S tablets, Betaxolol 10 mg and 20 mg tablets USP, Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets, Carisoprodol & Aspirin tablets, Carisoprodol 350mg tablets, Carisoprodol, Aspirin & Codeine tablets, Chlordiazepoxide w/ Clidinium Bromide capsules, Chlorzoxazone 250mg, Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets, Cilostazol tablets 100mg, Cyclobenzaprine HCL 5 mg and 10 mg, Dexchlorpheniramine Maleate 4 mg and 6 mg tablets, Dipyridamole 25 mg, 50mg, and 75 mg tablets, Glyburide 1.5 mg, 3.0 mg and 6.0 mg tablets, Guaifenesin & Codeine Phosphate tablets, Guaifenesin & Phenylephrine tablets, Guanfacine 1.0 mg and 2.0 mg HCl tablets, Hydrocodone & Homatropine tablets, Hydromorphone HCl tablets, Hydroxyzine 10 mg, 25 mg and 50 mg tablets, Hyoscyamine Sulfate 0.125 mg (oral) tablets, Hyoscyamine Sulfate 0.125 mg SL, Hyoscyamine Sulfate 0.375mg SR tablets, Isradipine 2.5 mg and 5 mg capsules, Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsules, Meclizine Chewable 25 mg tablets, Meloxicam 7.5 mg and 15 mg tablets, Meperidine & Promethazine capsules, Meperidine HCl 100 mg and 50 mg tablets, Methenamine Mandelate 0.5 g and 1.0 g tablets, Mirtazapine 15 mg, 30 mg, and 45 mg tablets, Mirtazapine OD tablets, 15 mg, 30 mg and 45 mg, Multi-ret Folic 500 mg tablets, Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets, Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets, Naltrexone 50mg tablets, Oxycodone & Acetaminophen 5/500mg capsules, Oxycodone HCl 5 mg capsules, Oxycodone HCl 5 mg, 15 mg and 30 mg tablets, Pentazocine & Acetaminophen tablets, Pentazocine & Naloxone tablets, Phenazopyridine HCl 100 mg and 200 mg tablets, Phendimetrazine Tartrate 35mg tablets, Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules, Phentermine HCl 37.5 mg tablets, Prenatal Formula 3 tablets, Prenatal Plus 27 mg FE tablets, Prenatal Rx tablets, Quinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets, Rifampin 300mg capsules, Sodium FL 0.5 mg and 1.0 mg tablets, Tizanidine HCl 2 mg and 4 mg tablets, Trimethobenzamide 300mg capsules, Trimipramine Maleate 25mg, 50mg, 100mg capsules, Trivita 1 mg FL tablets, Ursodiol capsules, 300mg, Vitacon Forte capsules, Vitaplex Plus tablets, Vitaplex tablets (FC), and Yohimbine HCl 5.4 mg tablets

According to the FDA’s press release, this action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications. The FDA says 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.

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