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Safety Information

Trans-Tasman Early Warning System - Alert Communication

m-Captopril tablets 12.5mg, 25mg, 50mg, 100mg — Manufacturing Issues

11 November 2013

Update

14 March 2014
This product has now been discontinued and is no longer available in New Zealand.

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

Medsafe is issuing this alert in relation to all strengths of m-Captopril because of issues identified at the manufacturing site. Medsafe has received information following an audit by overseas regulators which identified manufacturing issues at the site. At the moment the information Medsafe has received indicates that there is no immediate safety risk to patients taking this medicine. However, the level of assurance in relation to the overall quality of the product is lower than is required.

Products affected

This alert applies only to m-Captopril 12.5mg, 25mg, 50mg, 100mg (captopril), supplied to New Zealand by Multichem NZ Limited and manufactured by a Wockhardt Ltd site.

Information for consumers and caregivers

  • As there is no evidence that the medicine is unsafe, do not stop taking your medicine, and discuss your treatment with your prescriber at your next visit.
  • Talk to your healthcare professional if you have any concerns.
  • Report any adverse events to the Centre for Adverse Reactions Monitoring (CARM).

 

Information for healthcare professionals/suppliers

  • Depending on any further information Medsafe receives, a recall of m-captopril may be required in the future. You will be kept informed and any recall will be conducted in the usual way.
  • PHARMAC has advised Medsafe that the funding for the ACE inhibitor captopril may cease from 2014. Given this, PHARMAC advises that prescribers should now consider moving patients from captopril to another ACE-inhibitor or other suitable treatment at the next patient visit. You should not start new patients on captopril.
  • Following cessation of funding, patients currently taking captopril may need to be changed to an alternative treatment. This can be done at their next routine appointment.
  • There is no need to contact patients. Any changes of medication can be performed at the next appointment.

Data summary

Medsafe is issuing this alert in relation to all strengths of m-Captopril because of issues identified at the manufacturing site.  At the moment, information suggests that there is no immediate safety risk to patients taking this medicine. However, the level of assurance in relation to the overall quality is lower than is required.

What action is Medsafe taking?

Medsafe continues to obtain and assess information in relation to the issue. Medsafe is working with Multichem (the company responsible for marketing the product in New Zealand) and PHARMAC to resolve this issue.

How to report

Post Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415.
Email recalls@moh.govt.nz
Fax 04 819 6806

Further information

 

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