Q: Why were the products recalled?
A: This is a voluntary recall to the retail level only, not the consumer level. A recent inspection revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices. Actavis Totowa is recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals.
Q: Are all Actavis Totowa products impacted by this recall?
A: No, the following products are not manufactured in the Little Falls, New Jersey facility and therefore are not impacted by this recall:
- Amlopidine Besylate tablets
- Desipramine HCl tablets
- Finasteride tablets
- Irinotecan HCl injection
- Ondansetron HCl tablets
- Orphenadrine Citrate ER tablets
Q: Are other Actavis entities impacted by this recall?
A: No. Actavis Elizabeth LLC, Actavis South Atlantic LLC, Actavis Mid Atlantic LLC and other Actavis sites are not impacted by this recall.
Q: Is it safe to continue taking these products?
A: Consumers who have these medicines in their possession may continue to take them in accordance with their prescriptions. If patients are concerned and wish to consider switching medicines, they should first consult with their health care providers or pharmacists. In many cases, the risk of suddenly stopping needed medication before obtaining replacement drugs may place patients at risk.
Q: When will recalled product return to the market?
A: We are in the process of implementing corrective actions at the Little Falls facility and are working quickly and carefully to return products to the market. We cannot provide specific dates at this time.
Q: How do I know if my tablets are being recalled?
A: The recalled products manufactured at the Little Falls, NJ facility are listed below.
Q: How can I return product?
A: (Consumer): This recall is to the pharmacy level, which means that consumers are not being asked to return their product.
A: (Retailer/Wholesaler): Please refer to the recent recall letter that was sent to all of our retail and wholesale customers.
Q: What are my options as a consumer?
A: If you are not comfortable taking the product, please consult with your doctor before discontinuing this medication and ask your doctor or pharmacist about your options.
Q: What are the alternatives that I can take?
A: Please consult with your doctor or pharmacist to get alternative prescriptions.
Q: Where are these products made?
A: They are manufactured in New Jersey, USA.
Recall Product List:
|
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 |