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Stievamycin Regular Gel (Tretinoin 0.025% Erythromycin 4%) 45g (September 27, 2012)

Starting date:
September 27, 2012
Posting date:
October 15, 2012
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-26255

Reason

Lot L1651 of Stievamycin Regular Gel 45g has been found to have concentrations of Tretinoin that are lower than the label claim of 0.025% for this ingredient.

Depth of distribution

Wholesalers and Pharmacies

Affected products

Stievamycin Regular Gel (Tretinoin 0.025% Erythromycin 4%) 45g

DIN, NPN, DIN-HIM

DIN 01905112

Dosage form

Topical Gel

Strength

  • Tretinoin 0.025%
  • Erythromycin 4%

Lot or serial number

L1651

Companies

Recalling Firm
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga Ontario
Canada L5N 6L4
Marketing Authorization Holder
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga Ontario
Canada L5N 6L4