Recalls & Alerts Published by NAFDAC

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.

The attention of the Agency has been drawn to the alert by FDA regarding compounded or repackaged drugs stored in Becton-Dickson (BD) general use syringes, 1ml, 3ml, 5ml, 10ml, 20ml and 30ml syringes. The alert was based on Becton-Dickson reports that an interaction on the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately. These syringes have been cleared as medical devices for general purpose fluid aspiration and injection only and not for use as closed container storage system for drug products as the suitability of these syringes for that purpose have not been established.

The drugs that have been reported by Becton-Dickson to be affected by the stoppers include fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium and remifetanyl.

Action required from Prescriber/Patients

NAFDAC…….Safeguarding the health of the Nation.

Thursday, 20 August 2015 11:55

Public Alert On Falsified Diazepam

The Agency has been notified of the confirmed circulation of falsified Diazepam tablets in Central Africa. This information was revealed on the 2nd of July, 2015 by the World Health Organization (WHO). Laboratory analysis report of a product labeled as Diazepam shows that it does not contain diazepam but contains between 10mg to 20mg of Haloperidol per tablet an anti-psychotic used for the treatment of schizophrenia. The tablets are light yellow, scored on one side and bear AGOG on the other side are contained in white plastic bottles of 1000 tablets. AGOG a pharmaceutical manufacturer have stated they do not manufacture Diazepam but manufacture Haloperidol with a similar description but supplied in blisters of 10 tablets and boxes of 10 blisters under the trade name of AGOHAL, Haloperidol tablet BP 10mg. The tablet marked with the trade name SOLINA, Diazepam tablet BP 5mg manufactured by CENTAUR Pharmaceuticals tested positive for Haloperidol.

According to CENTAUR Pharmaceutical, they do not manufacture Haloperidol but manufacture Diazepam. Report have also shown that over 400 patients in the north east region of the Democratic Republic of Congo (DRC) have suffered from an acute dystonic reaction affecting the muscles of the face, neck and tongue which is a known side effect of Haloperidol.

The falsified version of Diazepam labeled as manufactured by AGOG Pharma Ltd is being circulated in containers of 1000 tablets. AGOG Pharma has confirmed this labeling and packaging to be falsified and should not be used as they do not manufacture Diazepam.

Details of affected batches are:

Product 1

Product 2

Manufacturer: CENTUER Pharmaceuticals Ltd

Trade name: SOLINA

Product:   Diazepam BP 5mg

Batch Number: SBG038

Manufacturing date: September 2014

Expiry date: August 2017

Manufacturer: AGOG Pharma. Ltd


Product:   Diazepam BP 5mg

Batch Number: 2332

Manufacturing date: November 2013

Expiry date: October 2016

NAFDAC warns that health care providers and the general public should ensure vigilance and careful examination of product content bearing the above details. Also notify the Agency of any information concerning the supply of these products 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

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