GSK Voluntary Recall of Clavulin -400 Oral Suspension Lot # 710535

On April 17, 2015 GSK issued a voluntary recall of Clavulin-400 Oral Suspension (Lot number 710535), an antibiotic which is used to treat various bacterial infections , from patients, pharmacies, hospitals and wholesalers in Canada. GSK made this decision as a precautionary measure after being alerted by a pharmacy that a single bottle of Clavulin-400 Oral Suspension from Lot number 710535 was found to contain two glass pieces, approximately 1.5 cm each in size.

Patient safety is our first priority and we are compelled to proceed with caution and urgency in this matter. Upon notification, we took immediate steps to investigate the situation, advise regulators, and proceed to voluntarily recall from Canadian patients, pharmacies, hospitals and wholesalers all existing units of Clavulin-400 Oral Suspension from Lot number 710535 as a precaution.

Wholesalers, hospitals, pharmacies and patients are asked to immediately return to their respective place of purchase all stock of Clavulin-400 Oral Suspension from Lot number 710535. If there are any concerns by persons who have ingested Clavulin-400 Oral Suspension, or their caregivers, they should consult their healthcare provider immediately.

GSK is currently conducting a thorough investigation and actions will be taken to help prevent a recurrence. Other than this single report, we have received no other reports of similar situations related to any other bottle of Clavulin-400 Oral Suspension currently on the market.

Health Canada and the Medicines & Healthcare products Regulatory Agency (MHRA) in the U.K. have been notified of the situation.

GSK enquiries 

Canada:

Corporate Communications +1 905-819-3363 (Mississauga)  
  +1 450-680-4812 (Laval)  

1 Clavulin-400 Oral Suspension is indicated for: Sinusitis when caused by β -lactamase producing strains of H. influenzae or Moraxella (Branhamella) catarrhalis. Otitis Media when caused by β-lactamase producing strains of H. influenzae or Moraxella (Branhamella) catarrhalis.
Lower Respiratory Tract Infections when caused by β-lactamase producing strains of H. influenzae, K. pneumoniae, S. aureus or Moraxella (Branhamella) catarrhalis.
Skin and Soft Tissue Infections when caused by β-lactamase producing strains of S. aureus.
Urinary Tract Infections when caused by β-lactamase producing strains of E. Coli

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