Public recall detail

Apo-Acyclovir Tablets: NDMA impurity (Updated with new product and lot numbers)

2022-04-28

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Recall Safety notice
Quick summary

Quick summary: Apo-Acyclovir Tablets: NDMA impurity (Updated with new product and lot numbers). Date: 2022-04-28.

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-Acyclovir Tablets: NDMA impurity (Updated with new product and lot numbers). Date: 2022-04-28.

Official details

Affected product details

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

BrandApotex
ProductApo-Acyclovir Tablets
IssueHealth products - Contamination
Recall classType I
IdentificationRA-64118

Affected products

BrandApotex
ProductApo-Acyclovir 200mg
DIN / NPN / authorizationDIN 02207621
Dosage formTablet
StrengthAcyclovir 200mg
LotRH9370, RH9368, RH9369, TF4466 New Lots: TE5048, TK5832
BrandApotex
ProductNew Product: Apo-Acyclovir 400mg
DIN / NPN / authorizationDIN 02207648
Dosage formTablet
StrengthAcyclovir 400mg
LotNew Lots: TH6095, TH6096, TH6098
BrandApotex
ProductApo-Acyclovir 800mg
DIN / NPN / authorizationDIN 02207656
Dosage formTablet
StrengthAcyclovir 800mg
LotRT8943, RP8516, RP8517, TE5062, TH6119 New Lots: TK1734, TK3921

Issue

Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA).

What you should do

  • Continue taking your medication unless you have been advised to stop by your health care provider. You do not need to return your medication to your pharmacy. Not treating your condition may pose a greater health risk.
  • Talk to your health care provider if you are taking a recalled product and are concerned about your health.
  • If you have questions about the recall, contact Apotex Inc. at 1-888-628-0732 or by email at apotex4315@sedgwick.com.
  • 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-64118
Background{}
CompaniesApotex Inc. 150 Signet Drive, Toronto, Ontario, M9L 1T9
AudiencesGeneral public Healthcare Industry
Source updated2023-08-14

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

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