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Jordan Berman
Vice President,
Global Corporate Communications

Apotex Inc.
  150 Signet Drive
North York,
ON, M9L 1T9
Canada

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Press Center

Feb 4, 2020
Voluntary Recall of APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets) 500mg Tablets.

Apotex has initiated a voluntary Type I recall to the Pharmacy Level for eight lots of “APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets) 500mg Tablets”. The lots identified in this communication exceeded the interim acceptable concentration limit for N-nitrosodimethylamine (NDMA) as established by Health Canada.  Considering 2000 mg/day the maximum daily dose of Metformin HCI ER, NDMA levels of 0.048 ppm will not change the risk benefit profile of the Product. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Consumers should continue taking their metformin drugs, as the risks from not having adequate diabetes treatment far outweigh any possible effects of exposure to the levels of NDMA seen in the recalled products. Please see the table below for potentially impacted product and lot numbers for further information:

PRODUCT

DIN

STRENGTH

SIZE/FORMAT

LOT

EXP. DATE (mm/yyyy)

APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets)

02305062

500mg

100 BTL

NV3242

04/2020

NV3244

04/2020

NV3245

04/2020

500 BTL

NV3243

04/2020

NV3247

04/2020

NV3248

04/2020

PX5334

01/2021

PX5335

01/2021

APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets) is indicated for the control of hyperglycemia in adult patients with type 2 (non-insulin-dependent, mature onset) diabetes, as an adjunct to dietary management, exercise, and weight reduction, or when insulin therapy is not appropriate. Apo-Metformin ER may be used as monotherapy, or concomitantly with a sulfonylurea. Apo-Metformin ER is a once-daily formulation, which must be taken with food to ensure optimum delivery of metformin to the systemic circulation. Clinical data demonstrates that administration of metformin hydrochloride in the fed state significantly increases the systemic delivery of metformin when compared to the fasted state. Metformin can be of value in the treatment of obese diabetic patients.

To report a suspected adverse reaction associated with the use of APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets) patients may contact Apotex by calling 1-800-667-4708 (select prompt 2), by email at drugsafety@apotex.com or by fax at 1-866-429-9133 or 416-401-3819.

Patients may also report any suspected adverse reactions associated with the use of health products to Health Canada by calling toll free at 1-866-234-2345 or by visiting MedEffect Canada's Web page on Adverse Reaction Reporting to https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax.