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Health product recall

NOVASEN 325mg ENTERIC COATED TABLETS (DELAYED RELEASE) (2017-11-27)

Starting date:
November 27, 2017
Posting date:
December 7, 2017
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-65338

Affected products

NOVASEN 325mg ENTERIC COATED TABLETS (DELAYED RELEASE)

Reason

Out of specification for disintegration during stability testing.

Depth of distribution

Wholesalers and retailers: Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Quebec and Saskatchewan

Affected products

NOVASEN 325mg ENTERIC COATED TABLETS (DELAYED RELEASE)

DIN, NPN, DIN-HIM
DIN 00216666
Dosage form

Tablet

Strength

325 mg

Lot or serial number
  • 35341402B
  • 35341404A
  • 35342267A
  • 35210910A
  • 35345386A
  • 35348141B
  • 35211624A
  • 35212006A
  • 35342267B
  • 35345386B
Companies
Recalling Firm
Teva Canada Limited 30 Novopharm Court Toronto, ON M1B 2K9
Marketing Authorization Holder
Teva Canada Inc. 30 Novopharm Court Toronto, Ontario M1B 2K9

Date modified: