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Safety Information

Trans-Tasman Early Warning System - Alert Communication

CONSUMER LEVEL RECALL - Maxiclear Sinus & Pain Relief and Maxiclear Cold & Flu Relief

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

22 September 2017

Description

The consumer level recall of Maxiclear Sinus & Pain Relief and Maxiclear Cold & Flu Relief is being conducted because black mould has been found on the tablets. The mould is identified as belonging to Penicillium genus.

Products affected

The product is: Maxiclear Sinus & Pain Relief
Batch Number: Batch PPGEA7001A, expiry February 2020
The product is: Maxiclear Cold & Flu Relief
Batch Number: Batch PPGEB7001A, expiry February 2020

Information for consumers and caregivers

  • The products being recalled are:
    1. Maxiclear Sinus & Pain Relief - Batch PPGEA7001A, expiry February 2020
    2. Maxiclear Cold & Flu Relief - Batch PPGEB7001A, expiry February 2020
  • If you have purchased any stock of Maxiclear Sinus & Pain Relief and/or Maxiclear Cold & Flu Relief tablets, please check the batch number to see if you have product affected by the recall.
  • The batch number can be found on the ends of each blister strip and on the end flap of the carton (right hand side when looking at the carton front panel).
  • If you are in possession of either of these batches of product, please stop using the product immediately.
  • Affected products may be returned to your pharmacy for a replacement or refund.
  • Alternatively you may contact AFT Pharmaceuticals Ltd on 0800 423 823 or by email on customer.service@aftpharm.com for more information on how to return the product directly to AFT Pharmaceuticals Ltd who will then send you replacement product once it becomes available.


Maxiclear Sinus & Pain Relief Maxiclear Cold & Flu Relief

Information for healthcare professionals

  • This consumer level recall only applies to:
    1. Maxiclear Sinus & Pain Relief - Batch PPGEA7001A, expiry February 2020
    2. Maxiclear Cold & Flu Relief - Batch PPGEB7001A, expiry February 2020
  • Please inspect your stock and quarantine all units from either of these batches of product.
  • If you have purchased affected stock from a wholesaler, please return recalled stock back to the wholesaler. All returned stock will be credited or replaced on receipt from the wholesaler.
  • AFT Pharmaceuticals is instructing consumers to return affected stock back to the pharmacy from which the product was purchased from for a refund or replacement.
  • Consumers have also been advised that they are also able to contact AFT Pharmaceuticals Ltd on 0800 423 823 or by email on customer.service@aftpharm.com for more information on how to return the product directly to AFT Pharmaceuticals Ltd. AFT Pharmaceuticals Ltd will then send a replacement product to the consumer once it becomes available.

What action is Medsafe taking?

Monitoring the consumer level recall and any adverse events that may be reported.

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.

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