Public recall detail

APO-AMITRIPTYLINE 10mg: NDMA Impurity

2023-02-07

medium
Recall Safety notice
Quick summary

Quick summary: APO-AMITRIPTYLINE 10mg: NDMA Impurity. Date: 2023-02-07.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: APO-AMITRIPTYLINE 10mg: NDMA Impurity. Date: 2023-02-07.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAPO-AMITRIPTYLINE
ProductAPO-AMITRIPTYLINE 10mg
IssueHealth products - Contamination Health products - Product safety
Recall classType I
IdentificationRA-72672

Affected products

BrandAPO-AMITRIPTYLINE
ProductAPO-AMITRIPTYLINE
DIN / NPN / authorizationDIN 02403137
Dosage formTablet
Strength10 MG
LotPY1904

Issue

Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-month stability testing timepoint.

What you should do

  • Patients can continue to take their medication as prescribed by their health care provider as there is no immediate risk in continuing to take the recalled medication. Stopping amitriptyline may lead to mild withdrawal symptoms.
  • Contact your health care provider if you have taken a recalled product and you have concerns about your health. Ask your pharmacist if you are unsure whether you are taking a recalled product.
  • Contact the company if you have questions about the recall: Apotex Inc. via Sedgwick by calling at 1-866-875-0382, or by email at apotex3904@sedgwick.com AA Pharma at 1-905-669-1565
  • Apotex Inc. via Sedgwick by calling at 1-866-875-0382, or by email at apotex3904@sedgwick.com
  • AA Pharma at 1-905-669-1565
  • Report any health product-related side effects or complaints to Health Canada.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesApotex Inc. 150 Signet Drive, Toronto, Ontario, M9L 1T9
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-72672
Background{}
CompaniesApotex Inc. 150 Signet Drive, Toronto, Ontario, M9L 1T9
AudiencesGeneral public Healthcare Industry
Source updated2023-02-07

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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