Health product recall

GUM Paroex (2020-12-24)

Starting date:
December 24, 2020
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74669

Last updated: 2020-12-29

Summary

  • Product: GUM Paroex

Reason

The affected lots may contain the presence of bacterial contamination.
Alternate Brand Names: Chlorhexidine Gluconate Oral Rinse USP 0.12%

Depth of distribution

Wholesalers, Retailers, Healthcare establishments

Affected products

GUM Paroex

DIN, NPN, DIN-HIM

DIN 02384272

Dosage form

Mouthwash

Strength

Chlorhexidine Gluconate 0.12%

Lot or serial number

Additional lots:
A333LF, A333LG, A333LH, A333LJ, B003HM, B003HN, B003HP, B003HQ, B003HR, B003HS, B003HT, B009JG, B009JH, B009JJ, B066LG, B070AP, B070AQ, B070AR, B136HM, B141HU, B141HV, B141HW, B178FL, B178FM, B178FN, B199KR, B199KS, B199KT, B227DX, B227EK, B227EL, B234FD, B234FE, B234FF, B304LB, B304LC, B311AM, C009LV, C009LW, C016BH, C030HH, C030HJ, C030HK, C142DF, C142DG, C142DH, C142DJ, C142DK, B009JK, B009JL, B031CD, B227DW, C016BJ

Companies

Recalling Firm
Sunstar Americas Inc.
515 Governors Road
Guelph
N1K 1C7
Ontario
CANADA
Marketing Authorization Holder
Sunstar Americas Inc.
515 Governors Road
Guelph
N1K 1C7
Ontario
CANADA