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Health product recall

ratio-Atorvastatin recall (2014-07-08)

Starting date:
July 8, 2014
Posting date:
July 17, 2014
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-40675

Recalled products

  1. ratio-Atorvastatin 10 mg
  2. ratio-Atorvastatin 20 mg
  3. ratio-Atorvastatin 40 mg
  4. ratio-Atorvastatin 80 mg

Reason

Stability out-of-specification results at the 12-month time-point for an impurity.

Depth of distribution

Wholesalers and retailers across Canada

Affected products

A. ratio-Atorvastatin 10 mg

DIN, NPN, DIN-HIM

DIN 02350297

Dosage form
  • Tablet
Strength
  • 10 mg
Lot or serial number
  • 35329653E
  • 35329655B
  • 35332867A
  • 35329653D
  • 35329654C
  • 35331730A
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. ratio-Atorvastatin 20 mg

DIN, NPN, DIN-HIM

DIN 02350319

Dosage form
  • Tablet
Strength
  • 20 mg
Lot or serial number
  • 35330655C
  • 35332981A
  • 35206789A
  • 35330656A
  • 35330657A
  • 35206790A
  • 35206041A
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



C. ratio-Atorvastatin 40 mg

DIN, NPN, DIN-HIM

DIN 02350327

Dosage form
  • Tablet
Strength
  • 40 mg
Lot or serial number
  • 35329657E
  • 35329657D
  • 35329657F
  • 35329658B
  • 35205661A
  • 35206094A
  • 35206618A
  • 35329658D
  • 35329659B
  • 35332883A
  • 35206142A
  • 35206619A
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



D. ratio-Atorvastatin 80 mg

DIN, NPN, DIN-HIM

DIN 02350335

Dosage form
  • Tablet
Strength
  • 80 mg
Lot or serial number
  • 35329660B
  • 35329661B
  • 35329662B
  • 35332813A
  • 35206368A
  • 35206791A
  • 35206792A
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