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Health product recall

CellChem Pharmaceuticals Hot lemon relief for symptoms of cold and flu product recall (2021-09-16)

Starting date:
September 16, 2021
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-76529



Last updated:
2021-09-28

Summary

  • Product:
    A. Hot Lemon Relief for Cold and Flu Extra Strength

    B. Hot Lemon Relief for Cold and Flu Regular Strength

A. Hot Lemon Relief for Cold and Flu Extra Strength

B. Hot Lemon Relief for Cold and Flu Regular Strength

Reason

All lots are being recalled as no stability data to support affected lots' shelf life. Lot HLE0001 is out of specification for uniformity of dosage units.

Depth of distribution

Wholesalers

Affected products

A. Hot Lemon Relief for Cold and Flu Extra Strength

DIN, NPN, DIN-HIM

DIN 02238890

Dosage form

powder for solution

Strength

Acetaminophen 650mg, Phenylephrine Hydrochloride 10mg, Ascorbic Acid 50mg, Pheniramine Maleate 20mg

Lot or serial number

  • B004086
  • B004086A
  • B004086B
  • B004086C
  • B004086D
  • B004086E
  • B004086F
  • B006244
  • B006244A
  • B006244B
  • B006244C
  • B006244C
  • B006678A
  • B006678B
  • B006678C
  • B006678D
  • B010269
  • B010269A
  • B010269B
  • B010269C
  • B010269D
  • 209981
  • B014857
  • HLE0001
  • vHLE0003

Companies

Recalling Firm

CellChem Pharmaceuticals Inc

2000 Argentia Road, Plaza 2, Suite 220

Mississauga

L5N 1V8

Ontario

CANADA

Marketing Authorization Holder

CellChem Pharmaceuticals Inc

2000 Argentia Road, Plaza 2, Suite 220

Mississauga

L5N 1V8

Ontario

CANADA


B. Hot Lemon Relief for Cold and Flu Regular Strength

DIN, NPN, DIN-HIM

DIN 02047349

Dosage form

Powder for solution 

Strength

Acetaminophen 325mg, Phenylephrine Hydrochloride 10mg, Ascorbic Acid 50mg, Pheniramine Maleate 20mg

Lot or serial number

B004988, B004988A, B004988B, B007994, B007994A, B007994B, B007994C, 209984, B014856, HLR0001, HLR0002

Companies

Recalling Firm

CellChem Pharmaceuticals Inc

2000 Argentia Road, Plaza 2, Suite 220

Mississauga

L5N 1V8

Ontario

CANADA

Marketing Authorization Holder

CellChem Pharmaceuticals Inc

2000 Argentia Road, Plaza 2, Suite 220

Mississauga

L5N 1V8

Ontario

CANADA