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Health product recall

Proctol suppositories (2014-06-23)

Starting date:
June 23, 2014
Posting date:
August 12, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40765

Recalled Products

Proctol suppositories

Reason

Failure of the stability program at 24 month interval due to Framycetin sulfate assay not conforming to specifications.

Depth of distribution

Wholesalers and retailers in Canada.

Affected products

Proctol suppositories

DIN, NPN, DIN-HIM
DIN 02247882
Dosage form

Suppository

Strength
  • Hydrocortisone 5 mg
  • Framycetin sulfate 10 mg
  • Dibucaine Hydrochloride 5 mg
  • Esculin 10 mg
Lot or serial number
  • 128789A
  • 128789C
Companies
Recalling Firm
Odan Laboratories Ltd
325 Stillview Avenue
Pointe Claire
H2R 2Y6
Quebec
CANADA
Marketing Authorization Holder
Odan Laboratories Ltd
325 Stillview Avenue
Pointe Claire
H2R 2Y6
Quebec
CANADA

Date modified: