Pharmaceutical manufacturer Actavis Totowa announced a voluntary recall of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility. The recall follows an inspection conducted by the Food & Drug Administration earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards.

Actavis acknowledges that the Little Falls facility does not meet the company’s own standards for good manufacturing practices. As a result, Actavis made the decision to recall products manufactured at that facility at the pharmacy/retail level, including wholesalers and hospitals. Actavis has notified the FDA of this action.

Earlier this year, in April 2008, Actavis Totowa issued a Class I recall of its Digitek product, which is used to treat heart problems, after it was discovered that tablets may have been manufactured at twice their intended thickness, doubling the amount of medication in the pills and putting patients at risk for serious complications as a result of higher dosages than intended.

The company says there have NOT been any product complaints or negative health incidents reported involving products affected by this new recall, but it is recalling the drugs as a precaution. All of the recalled products are prescription medications.

The manufacturer recommends that patients currently taking the affected medications should NOT stop taking the drugs, as a sudden stop in medication could be dangerous, but patients should consult with their physician or pharmacist for replacement medication.

Actavis Totowa has issued recall letters to wholesalers and retailers. Following is a list of recalled drugs:

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)

Yohimbine HCl 5.4 mg tablets


For more information, visit Actavis Totowa online.

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