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Medication Safety Alerts

Paliperidone Extended-Release 3 mg tablets Voluntary Recall

6/15/2017

On June 15, 2017, the United States Food and Drug Administration (FDA) announced that Teva Pharmaceuticals is voluntarily recalling paliperidone extended-release 3 mg tablets NDC # 00591-3693-19. This recall was issued because the product might not dissolve like it should.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number 1160682A exp. 6/2018. If your prescription was filled in the manufacturer’s bottle, please check the lot number. The lot number is on the next to the barcode on the right hand side of the manufacturer’s label. If your product is not from lot number 1160682A, it is not affected by this recall. If your product is from lot number 1160682A or if your prescription was not filled in the manufacturer’s bottle please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently taking paliperidone extended-release 3 mg tablets and have questions regarding this recall, please call your doctor or call Teva Pharmaceuticals toll-free at 1-888-838-2872 and select option 3 then option 4, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at https://www.fda.gov.

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