Public recall detail

Apo-Amitriptyline: Affected lots may exceed the interim acceptable intake limit for NNORT

2024-10-17

medium
Recall Safety notice
Quick summary

Quick summary: Apo-Amitriptyline: Affected lots may exceed the interim acceptable intake limit for NNORT. Date: 2024-10-17.

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: Affected lots may exceed the interim acceptable intake limit for NNORT. Date: 2024-10-17.

Official details

Affected product details

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

BrandApotex Inc., Apo
ProductApo-Amitriptyline
IssueHealth products - Product safety
Recall classType I
IdentificationRA-76352

Affected products

BrandApo
ProductApo-Amitriptyline
DIN / NPN / authorizationDIN 02403137
Dosage formTablet
StrengthAmitriptyline Hydrochloride 10 mg
LotRN6384, RR0265, RR0266, RV1644, RV1645, RW8597, RW8598, TA6008, TA6009, TF8585, TF8586, TF8587, TF8588, TF8589, TW2842, TW2843
BrandApo
ProductApo-Amitriptyline
DIN / NPN / authorizationDIN 02403145
Dosage formTablet
StrengthAmitriptyline Hydrochloride 25 mg
LotRM0519, RM8130, RR0780, RR0781, RV1656, RV1657, RW8691, TA6061, TA6062, TF8602, TF8603

Issue

Affected lots exceed or may exceed the interim acceptable intake limit for N-nitroso-nortriptyline (NNORT)

What you should do

  • Verify if your product is affected.
  • Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  • Contact the recalling firm if you have any questions about the recall.
  • Report any health product related side effects to Health Canada.
  • Report any other health product safety complaints to Health Canada.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesApotex Inc 150 Signet Drive, Toronto, ON Canada M9L 1T9
DistributionAlberta British Columbia Manitoba Newfoundland and Labrador Nova Scotia Ontario Quebec Saskatchewan
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-76352
Background{}
CompaniesApotex Inc 150 Signet Drive, Toronto, ON Canada M9L 1T9
AudiencesGeneral public Healthcare Industry
Source updated2024-10-17

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

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