Recalls & Alerts Published by NAFDAC

The attention of the Agency has been drawn to the South Korea Ministry of Food and Drug Safety (MFDS) resolution to maintain approval for the sale of Contentious lung cancer treatment medication called Olmutinib sold under the Trade Name Olita Tab.

Olmutinib, also known as HM61713 or BI14829 a third-generation lung cancer therapy has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI).

It has been a breakthrough therapy for patients who have developed a tolerance to existing lung cancer treatments. The ministry however, stressed that Healthcare providers should receive consent form from patients before using the drug, in order to provide a treatment opportunity for patients who have no alternative treatment.

INFORMATION ON PRODUCT

  • Manufacturer: Hanmi Pharmaceuticals Company, South Korea.
  • Drug name: Olmutinib sold under the trade name Olita Tab.

In view of this, the:

Patients taking Olmutinib should contact their health care professionals right away if they experience symptoms or any adverse effect related to the use of this product.

Healthcare professionals are implored to report adverse effect or side effects related to the use of these products 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!!!

Tuesday, 17 January 2017 14:26

Revocation Of Marketing Authorization

The National Agency for Food and Drug Administration and control (NAFDAC) hereby alerts the general public on the revocation of the marketing authorizations granted to Sonia Food Industries Limited. The revocation is based on the refusal of the manufacturer, Vitasoy International Holdings Limited, Hong Kong to respond and facilitate the inspection of their production facility by a team of NAFDAC inspectors who were in Hong Kong to conduct the Good Manufacturing (GMP) inspection.

The address of the manufacturer is: Vitasoy International Holdings Limited. 1 kin Wong Street               Tuen Mun, New Territories, Hong Kong

The affected products are:

  1. Vitasoy Malted Soya bean Milk (350g can)                                    A1-2897
  2. Vitasoy Soya Milk (300ml Glass bottle)                                         A1-0305
  3. Vitasoy Soya Milk (350ml can)                                                     A1-3047
  4. Vitasoy Chocolate Flavored Soya Drink (250ml Tetra Pak)             A1 -2928
  5. Vitasoy Soya bean Drink (250ml Tetra Pak)                                  A1-2896

NAFDAC implores the general public to desist from purchasing and consuming these products as their quality and safety cannot be guaranteed.

The distribution and retail outlets that have stock of these products are advised to submit them to the nearest NAFDAC office.

NAFDAC………Safeguarding the health of the nation!!!

The National Agency for Food and Drug Administration and Control has been informed that the Hong kong Centre for Food Safety on the 18th August, 2016 warned the public to stop the sale and use of plasticizer-tainted Bottle-Tartare Sauce imported from the United kingdom (UK) over containment of plasticizer, known as Di-Isodecyl Phthalate (DIDP). DIDP is a type of phthalate plasticizer which is added to materials such as hard plastics to improve their flexibility and durability. The brand marketed stokes contained DIDP at a level of 380 parts per million (ppm), which exceeded the action level of 9ppm adopted by the CFS on related compounds.

Details of the product are as follows:

Food product: Bottle-Tatare Sauce

Product name: Tartare Sauce

Brand name:   Stokes

Manufacturer: Stokes Sauces

Place of origin: United Kingdom

Net weight:     200 grams

Expiry date:    31/07/16

NAFDAC implores importers to ensure that they do not import this food sauce. All outlets with products from these companies should immediately stop sale or distribution and submit products to the nearest NAFDAC office for appropriate action.

NAFDAC implores the general public to desist from using vaccines from the above mentioned companies.

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

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