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Health product recall

Teva-Ramipril (2.5 mg and 5 mg)

Starting date:
March 28, 2013
Posting date:
April 23, 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-26853

Recalled Products

  1. Teva-Ramipril (2.5 mg)
  2. Teva-Ramipril (5mg)

Reason

Product stability testing shows that the lot will likely have results above its specification limit for the total impurities test before the labelled expiry date.

Depth of distribution

Lot was distributed to wholesalers and retailers in NF, QC, ON, MB, BC.
Lot was also distributed to compassionate drug programs in ON.

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
  • 35328352B
Companies
Recalling Firm
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA

B. Teva-Ramipril 5 mg

DIN, NPN, DIN-HIM
DIN 02247946
Dosage form
  • Capsule
Strength
  • 5 mg
Lot or serial number
  • 35328356B
Companies
Recalling Firm
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA