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

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