Glass Fragments in Liquid Amoxicillin Prompts Recall

Glass Fragments in Actavis brand of Oral Liquid Amoxicillin Prompts Recall

17 July 2014

Glass fragments found in two bottles of the Actavis brand of amoxicillin oral liquid have prompted a recall by the company.

There have been no reports of any harm from the glass being in the bottles. The recall has occurred as a precautionary measure as the glass fragments found in the bottles appear to have been broken off from the lip of the bottle during manufacturing of the product.

Anyone prescribed amoxicillin liquid by their doctor is advised to check if it is the Actavis brand and if it is to stop using it and contact their GP or pharmacist for a replacement. This brand of amoxicillin has only been used widely since the beginning of this month.

Amoxicillin is a frequently prescribed antibiotic and is often used for treatment in children for glue ear, chest, skin and urinary tract infections. It is also used for other less common conditions.

Only the oral liquid Actavis Amoxicillin is affected. The capsule form and other brands of amoxicillin are not affected and alternative antibiotics to amoxicillin are available.

Actavis Amoxicillin oral liquid is packaged in glass bottles and is available in two strengths 125mg/5ml and 250mg/5ml.

Medsafe has provided information to health professionals about the recall. Anyone wanting advice is advised to call Healthline 0800 611 116 or Plunketline 0800 933 922.

Products Affected

Amoxicillin Actavis Powder for oral suspension (125 mg/5 ml and 250 mg/5 ml).

Key Information For Consumers and Caregivers

• Do not give any further doses of Amoxicillin Actavis oral liquid.

• Contact your doctor or pharmacist for further advice. Your doctor may give you an alternative brand of amoxicillin, an alternative antibiotic or alternative treatment.

This recall only applies to the Actavis brand of amoxicillin oral liquid.

Any charge for health services provided as a result of this recall are at the discretion of the GP or pharmacist.

ADDITIONAL INFORMATION

How much Actavis brand Amoxicillin is on the market: It is estimated that up to 60,000 bottles are in the distribution chain. The bulk of this will be stopped and either held or returned to the distributor.

How much Actavis brand Amoxicillin is held by consumers: It is estimated that between 10,000 and 20,000 bottles are likely to have been dispensed to individuals since it became a fully subsidised medicine in NZ on 1 July 2014

What should people do if they have been prescribed amoxicillin liquid: They should check if it is the Actavis brand. If it is they should stop using it and contact their GP or pharmacist as soon as possible to arrange a replacement. If they are concerned they should contact Healthline 0800 611 116 or Plunketline 0800 933 922. If in doubt talk to your pharmacist or GP.

What is amoxicillin prescribed for: Amoxicillin is a frequently prescribed antibiotic and is often used for treatment in children of for glue ear, chest, skin and urinary tract infections. It is also used for other less common conditions.

Are other brands of amoxicillin available: There is a limited supply of alternative brand liquid amoxicillin. There are a number of alternative antibiotics available that are suitable and are Government funded.

What happens if my child misses a dose of medicine before the medicine is able to be replaced: In most cases, a child with a simple infection can miss a single dose of an antibiotic without concern. Anyone concerned or seeking advice should contact their doctor or ring Healthline or Plunketline.

Do I have to pay to see the doctor or to pick up a new medicine from the pharmacist: Any charge for services provided as a result of the recall are at the discretion of the GP or pharmacist. The Ministry expects a significant number of those affected would be under six years of age. Both the GP visit and pharmacy prescription charge are fully funded by the Government and there would generally be no charge for this.

Has anyone been harmed as a result of glass in the amoxicillin: There have been no reports of harm.

How did the glass get in the bottles: The bottles are made of glass and in the two cases reported the glass appears to have been broken from the lip of the bottle. As a precautionary measure the bottles have been recalled. Both the company making and distributing the medicine and Medsafe are investigating the cause of the glass being found in the two bottles.

Who found the glass in the bottles and when was it reported: Pharmacists found the glass fragments when they were preparing the oral solution for supply to patients, they alerted the product supplier who in turn alerted Medsafe on the afternoon of 15 July.

Why wasn't the glass in the bottles found before the bottles were distributed: The glass fragments appear to have been displaced during the manufacturing process of the product. As the bottles are sealed with an aluminium foil cap it is not possible to visually identify damage to the lip of the bottle during or after the manufacturing process. The fragments have been found in the powder contained within two bottles of the product. Visual inspection will not identify glass fragments within this antibiotic powder.

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