Health product recall

Mylan Pharmaceuticals Product Recall (2018-11-27)

Starting date:
November 27, 2018
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68754

Recalled Products

  1. Mylan-Valsartan 160mg Tablets
  2. Mylan-Valsartan 320mg Tablets
  3. Mylan-Valsartan 40mg Tablets
  4. Mylan-Valsartan 80mg Tablets

Reason

An impurity out of specification is expected near the expiry date in the affected lots.

Depth of distribution

Wholesalers, Retailers

Affected products

A. Mylan-Valsartan 160mg Tablets

DIN, NPN, DIN-HIM

DIN 02383543

Dosage form

Tablet

Strength

Valsartan 160mg

Lot or serial number

3056371

Companies
Recalling Firm

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA

Marketing Authorization Holder

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA


B. Mylan-Valsartan 320mg Tablets

DIN, NPN, DIN-HIM

DIN 02383551

Dosage form

Tablet

Strength

Valsartan 320mg

Lot or serial number

3048815-1

Companies
Recalling Firm

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA

Marketing Authorization Holder

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA


C. Mylan-Valsartan 40mg Tablets

DIN, NPN, DIN-HIM

DIN 02383527

Dosage form

Tablet

Strength

Valsartan 40mg

Lot or serial number

3048813-1

Companies
Recalling Firm

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA

Marketing Authorization Holder

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA


D. Mylan-Valsartan 80mg Tablets

DIN, NPN, DIN-HIM

DIN 02383535

Dosage form

Tablet

Strength

Valsartan 80mg

Lot or serial number

3056368

Companies
Recalling Firm

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA

Marketing Authorization Holder

Mylan Pharmaceuticals ULC

85 Advance Road

Etobicoke

M8Z 2S6

Ontario

CANADA