Public recall detail

Mylan-Cinacalcet: Affected lots exceed the established acceptable intake limit for N-nitroso-cinacalcet.

2025-07-16

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Recall Safety notice
Quick summary

Quick summary: Mylan-Cinacalcet: Affected lots exceed the established acceptable intake limit for N-nitroso-cinacalcet.. Date: 2025-07-16.

Recommended action

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

Recall details

Quick summary: Mylan-Cinacalcet: Affected lots exceed the established acceptable intake limit for N-nitroso-cinacalcet.. Date: 2025-07-16.

Official details

Affected product details

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

BrandMylan - Cinacalcet 30mg, Mylan - Cinacalcet 60mg, Mylan - Cinacalcet 90mg, Mylan
ProductMYLAN-CINACALCET (30mg, 60mg & 90mg)
IssueHealth products - Product quality
Recall classType I
IdentificationRA-77730

Affected products

BrandMylan
ProductCinacalcet (30mg)
DIN / NPN / authorizationDIN 02434539
Dosage formTablet
StrengthCinacalcet Hydrochloride 30 mg
Lot3188963
BrandMylan
ProductCinacalcet (60mg)
DIN / NPN / authorizationDIN 02434547
Dosage formTablet
StrengthCinacalcet Hydrochloride 60 mg
Lot3199204 & 3199206
BrandMylan
ProductCinacalcet (90mg)
DIN / NPN / authorizationDIN 02434555
Dosage formTablet
StrengthCinacalcet Hydrochloride 90 mg
Lot3188964

Issue

The affected lots exceed the established acceptable intake limit for N-nitroso-cinacalcet.

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
CompaniesMYLAN PHARMACEUTICALS ULC 85 Advance Road Etobicoke ON M8Z 2S7
DistributionNational
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-77730
Background{}
CompaniesMYLAN PHARMACEUTICALS ULC 85 Advance Road Etobicoke ON M8Z 2S7
AudiencesGeneral public Healthcare Industry
Source updated2025-07-16

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

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