Safety Information

Trans-Tasman Early Warning System - Alert Communication

CONSUMER LEVEL RECALL - Amoxicillin Actavis Powder for oral suspension; glass fragments found in two bottles

Products affected
Information for consumers and caregivers
Information for healthcare professionals
Data summary
What action is Medsafe taking?
How to report
Further information

17 July 2014

Medsafe has been notified that glass fragments have been found in two bottles of Amoxicillin Actavis Powder for oral suspension (batch number 14248).

This issue may have arisen during the manufacturing or supply process. Therefore Medsafe is taking a precautionary approach and has requested that the supplier Actavis New Zealand Ltd recall all batches of Actavis Amoxicillin oral suspension.

Link to Ministry of Health media release

Products affected

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

Information for consumers and caregivers

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

 

Information for healthcare professionals

  • Do not prescribe or dispense any Amoxicillin Actavis Powder for oral suspension (125 mg/5 mL or 250 mg/5 mL) until further notice.
  • Switch to amoxicillin capsules if your patient is able to swallow capsules.
  • If an alternative liquid antibiotic is required other broad-spectrum antibiotics such as amoxicillin + clavulanic acid or erythromycin are available and funded.
  • This recall only applies to the Actavis brand of amoxicillin.

Data summary

Glass fragments have been found in two bottles of Amoxicillin Actavis Powder for oral suspension. Both bottles were from the same batch (batch number 14248), however the cause of this issue is currently unknown and may affect all batches.

What action is Medsafe taking?

A consumer level recall of both strengths of Amoxicillin Actavis Powder for oral suspension.

How to report

Phone +64 3 479 7247 to speak to a Medical Advisor at CARM.
Online Submit an online report
Prescribers can submit using the online reporting tool available in patient management software.
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail (address is on the card).
Email carmnz@otago.ac.nz
Fax +64 3 479 7150
Post Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415.
Online Complete a  Report
Email devices@moh.govt.nz
Fax +64 4 8199 6806

Further information

Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.