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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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