According to the company statement issued on Friday, “the inspection at Little Falls revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices.”
Though no product complaint or health hazard related to any product has come up till date, the recall is completely precautionary and voluntary. The action implies a pharmacy/retail level recall which includes wholesalers and hospitals.
Entailing 65 different prescription drugs, such as pain killers, antidepressants, diet medication and drugs for blood pressure and hypertension, only pharmacies and hospitals are intended to return the prescription drugs.
However, consumers are not being asked to return the drugs, as sudden stopping the needed medication before obtaining appropriate replacement drugs may place them at higher risk. So, patients using the drugs should continue their medications until told otherwise by a doctor, the drug manufacturer said.
Meanwhile, if consumers do wish to obtain replacement for their drugs, they should contact their health care professional or pharmacist.
Pharmaceuticals manufactured at other Actavis sites are not impacted by this recall, the company said.
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
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