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Thursday, 31 August 2017 11:00

Recall Of Paliperidone Extended Release Tablets 3mg By Teva Pharmaceuticals

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The U.S. FDA has notified the National Agency for Food and Drug Administration and Control has been informed that Teva Pharmceuticals USA, Inc; initiated a voluntary recall to retail level for one lot of Paliperidone Extended – Release Tablets 3mg.

The recall was carried out due to failing test results for dissolution.

Paliperidone Extended Release Tablet 3mg is indicated for the treatment of schizophrenia or schizoaffective disorder.

POSSIBLE ASSOCIATED RISKS

  • Taking the affected product for the treatment of schizophrenia or schizoaffective disorder could result in less absorption of the drug.

DETAILS OF AFFECTED PRODUCT

Product Name: Paliperidone Extended Release Tablet, 3mg

Product Manufacturer: Teva Pharmaceuticals USA, Inc.

Lot: 1160682A

Expiry Date: 6/2018

NDC: 0591-3693-19

HEALTHCARE PROVIDER’S ACTION

  • Healthcare Providers in possession of the affected product should stop distributing or using it. They should return it to the nearest NAFDAC office.
  • Report adverse events relating to the use of these medicines to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it. .

NAFDAC…………Safeguarding the Health of the Nation!!!

Read 2039 times Last modified on Thursday, 31 August 2017 11:04