Recalls & Alerts Published by NAFDAC

The National Agency for Food and Drug Administration and Control has been informed that Portugal's National Authority of Medicines and Health Products (INFARMED), on 24th May, 2017 in Lisbon recalled Cerazette (desogestrel). The recall by Merck Sharp and Dohme Ltd of the film-coated tablet pack of eighty-four (84) units was due to absence of leaflet in the packaging of the batch of the product.

Cerazette is a hormonal contraceptives pill used for preventing pregnancy. It contains an active ingredient desogestrel, which is a synthetic progestogen similar to the natural progestogens produced by the body. It is commonly known as the "mini pill" or progestogen-only pill (POP).

The details of the recalled product are as follows;

Product Details

Product Name -                                 Cerazette (Desogestrel 0.075mg)

Pack Size -                                       84tablets/ pack

Product Manufacturer -                      Merck Sharp and Dohme

Product Type -                                  Oral Contraceptives

Lot Number -                                     N005730

Expiry Date -                                    01/2020

Registration number (INFARMED) -    2798585

Healthcare Providers in possession of this batch of the product should immediately contact the nearest NAFDAC office.

NAFDAC...........Safeguarding the health of the Nation!!!

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!!!

The National Agency for Food and Drug Administration and Control have been informed that the American Academy of Paediatrics (AAP), on 17th May, 2017 in Washington DC, warned that the consumption of energy drinks by children and teenagers could lead to life threatening health complications including death.

APP cautioned that the ingredients contained in energy drinks have not been tested on children and so their safety cannot be guaranteed. It stated that most energy drinks contain caffeine equivalent to three (3) cups of coffee and as much as fourteen (14) teaspoons of sugar.

Caffeine is a stimulant, it acts on the body's central nervous thereby increasing alertness and reducing sleepiness.

NAFDAC alerts that energy drinks are unsuitable for toddlers and young children. Also, adolescents and pregnant women should exercise caution in the consumption of energy drinks.

NAFDAC.........Safeguarding the health of the Nation!!!

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