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Clavulin 400 (2015-04-17)

Starting date:
April 17, 2015
Posting date:
April 20, 2015
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-53017

Recalled products

  1. Clavulin 400

Reason

The bottle was inspected and it was confirmed that two pieces of glass 17x14x8 mm and 15x15x8 mm respectively were inside the bottle along with the reconstituted suspension. The bottle itself was intact indicating that the glass was introduced into the bottle.

Depth of distribution

Wholesalers, Hospitals, Pharmacies and Patients

Affected products

A. Clavulin 400

DIN, NPN, DIN-HIM
DIN 02238830
Dosage form

Powder for solution

Strength
  • Amoxicillin (Amoxicillin trihydrate) 400 mg / 5 mL
  • Clavulanic Acid (Clavulanate Potassium)  57 mg / 5 mL
Lot or serial number
  • (L) 710535
Companies
Recalling Firm
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga
L5N 6L4
Ontario
CANADA
Marketing Authorization Holder
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga
L5N 6L4
Ontario
CANADA