This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
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
- 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 02238830Dosage 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
Related AWRs
Clavulin-400 liquid oral antibiotic: One lot recalled after glass pieces found in one bottle
2015-04-17 | Health products