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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