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Health product recall

Teva Ramipril (2.5 mg and 5 mg)

Starting date:
February 14, 2013
Posting date:
March 5, 2013
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-23837

Recalled Products

A. Teva Ramipril 2.5 mg
B. Teva-Ramipril 5 mg

Reason

Confirmed OOS total impurities for the product at the 18 month stability time point.

Depth of distribution

Product was distributed to wholesalers and retail pharmacists in Alberta, British Columbia, Manitoba, Newfoundland and Labrador, Nova Scotia, Ontario, Quebec and Saskatchewan. The product was also distributed to educational programs in Manitoba, and in Ontario as gifts and for reasons of compassion.

Affected products

A. Teva Ramipril 2.5 mg

DIN, NPN, DIN-HIM
DIN 02247945
Dosage form

Capsule

Strength

2.5 mg

Lot or serial number

Lot 35323175B

Companies
Recalling Firm
Teva Canada Limited
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Limited
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA

Teva-Ramipril 5 mg

DIN, NPN, DIN-HIM
DIN 02247946
Dosage form

Capsule

Strength

5 mg

Lot or serial number

Lot 35320870B

Companies
Recalling Firm
Teva Canada Limited
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Limited
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA

Date modified: