Recalls & Alerts Published by NAFDAC

The attention of the Agency has been brought to the voluntary recall of Multivitamin capsules produced by Glades Drug in Pahokee, Florida. The recalled multivitamin capsule contains high amounts of Cholecalciferol.

Cholecalciferol (Vitamin D3) is useful in maintaining bone and teeth integrity hence it is administered in treatment of osteoporosis, osteomalacia, rheumatoid arthritis and tooth or gum disease. It is also given to prevent fractures and low calcium levels in people with kidney failure and used in the prevention and treatment of rickets – a disease which results from Vitamin D deficiency. Vitamin D is used in the management of high blood pressure and high cholesterol levels. It also boosts the immune system and aids the prevention of autoimmune diseases such as cancer.

Administration of high doses of the drug could lead to Vitamin D toxicity which may be severe and lead to life threatening outcomes if left untreated. Vitamin D toxicity which often occurs as a result of hypercalemia presents as confusion, increased urination, increased thirst, loss of appetite, vomiting and increased muscle weakness. Long term toxicity may cause kidney failure, increased calcium deposits in the blood and soft tissue, bone demineralization and pains.

Healthcare Provider/Patient’s action

NAFDAC… Safeguarding the health of the Nation!

The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified of the circulation of falsified Amoxverse and Ampiverse capsules in Democratic Republic of Congo (DRC). The notification was received from the World Health Organization (WHO) on 3rd November, 2015.

The Laboratory analysis of the products revealed that they do not contain any active ingredient. The purported manufacturer (UNIVERSE Ltd Kenya) stated on the label explained that they do not manufacture any Penicillin.

The falsified versions of the antibiotics labeled as manufactured by UNIVERSE Ltd Kenya are being circulated in plastic containers of 1000 capsules. It has been reported that these products have been found in private health care facilities in DRC.

The details of falsified products are:

AMOXVERSE

AMPIVERSE

Manufacturer: UNIVERSE Ltd Kenya

Trade name: AMOXVERSE

Product:  Amoxicillin 250mg

Batch Number: 21645

Manufacturing date: October, 2013

Expiry date: September, 2017

Presentation: Red and Orange Capsules of   250mg

Manufacturer: UNIVERSE Ltd Kenya

Trade name: AMPIVERSE

Product:   Ampicillin 250mg

Batch Number: 21645

Manufacturing date: October, 2013

Expiry date: September, 2017

Presentation: Red and Black Capsules of   250mg

NAFDAC hereby implores health care providers and the general public to be vigilant and ensure that any information in respect of importation, distribution or sale of the falsified Amoxverse and Ampiverse capsules is reported to the nearest NAFDAC office or the National Pharmacovigilance Center (NPC) via e-mail:  This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC…..Safeguarding the health of the Nation.

Monday, 28 September 2015 12:13

Fda Warns About Cases Of Rare Brain Infection

The attention of the Agency has been drawn to the use of Gilenya (fingolimod) which is an immunomodulator shown to benefit patients with relapsing forms of multiple sclerosis (MS). Following recent notification from Norvatis the manufacturer of Gilenya, FDA is warning that a case of progressive multifocal leukoencephalophathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for MS without prior or concurrent exposure to other immunosuppressant drugs. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs. Symptoms of PML are diverse and may include progressive weakness on one side of the body; clumsiness; vision problems; confusion, and changes in thinking, personality, memory and orientation. The progression of deficits can lead to severe disability or death. As a result, information about these recent cases is being added to the drug label.

Action required from Prescriber/Patients

  • Patients taking Gilenya should contact their health care professionals right away if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.
  •  Health care professionals should stop Gilenya and perform a diagnostic evaluation if PML is suspected.
  • Report adverse events or side effects related to the use of these products to NAFDAC PRASCOR system (send text to 20543 from all network providers) or via adverse event report forms or e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. .
  • Patients should be encouraged to do same.

NAFDAC……Safeguarding the health of the Nation.

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