Advisory - Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risks

Published: Apr 07, 2018

OTTAWA, April 6, 2018 /CNW/ -

Issue
Health Canada is advising Canadians that AA Pharma Inc. is voluntarily recalling two lots of Primidone tablets because they contain high levels of lead. The company has indicated that only the lots identified below are affected by this issue.

Primidone is a prescription anti-epileptic drug used to control seizures. Lead is a heavy metal and can pose serious health risks when too much is ingested, particularly by children, and pregnant and breastfeeding women.

Who is affected

  • Consumers who have bought or used the affected product

Affected product

 

    Product   Strength DIN          Size/Format  Lot Number Expiry
    -------   -------- ---          -----------  ---------- ------

    Primidone 125 mg       00399310  100 tablets  MT4040           05/2021
    --------- ------       --------  -----------  ------           -------

    Primidone 250 mg       00396761  100 tablets  MM3274           10/2020
    --------- ------       --------  -----------  ------           -------

 

What consumers should do

  • Return the product to your pharmacy for replacement as soon as possible if you have product from the affected lots.
  • Do not stop taking Primidone without talking to your doctor. Stopping Primidone suddenly can cause serious problems, including seizures that may not stop.
  • Consult with your health care professional if you have taken these tablets and have health concerns.
  • Contact AA Pharma Inc. via Stericycle by calling 1-888-228-5053 or by email at AAPharma7068@stericycle.com if you have questions about this recall.
  • Report adverse events to health products to Health Canada by calling toll-free at 1?866?234?2345, or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1?800?267?9675, or complete an online complaint form.

Additional information for pharmacies:

  • Retail and hospital pharmacies that have dispensed these products are being asked by the company to contact individuals who have received the impacted lots and to recover units from the impacted lot for return. The company has sent a notice to wholesalers and distributors to communicate the recall and advise on what to do.
  • Pharmacies may contact AA Pharma Inc. via Stericycle at 1-888-228-5053 for further information on the recall.

What Health Canada is doing
Health Canada is monitoring the company's recall. Should additional safety information be identified, Health Canada will take appropriate action and inform Canadians.

Background
Lead consumed in excessive amounts poses serious health risks because it may accumulate in vital organs of the body. Toxic effects include miscarriage and other reproductive effects, kidney and brain damage, abdominal pain, anemia, loss of appetite, constipation, fatigue, sleeplessness, irritability, headache, changes in blood pressure, weakness, concentration problems, weight loss, and dizziness. Children, and pregnant and breastfeeding women are the most susceptible to the toxic effects.

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