Published: 17 July 2014
Revised: 29 August 2023
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
Online |
Submit a CARM report Prescribers can also submit a report 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). |
CARMReport@health.govt.nz |
Post | Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415. |
Online | Complete a Report |
devices@health.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.