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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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10. Recalls

10.1. Medicine recalls

Table 56 Medicine recalls by reason for recall
  2015-16 2016-17
July to June
Reason for recall
Adverse reactions 0 1
Foreign matter 5 3
Illegal supply 1 0
Impurity and degradation 6 3
Labelling and packaging 18
Micro-organisms 4 2
pH 0 0
Potency 5 3
Sterility 1 0
Othera 17 13
Total 57 32
  1. 'Other' includes dissolution, physical defects, observed differences, variable content, diagnostic inaccuracy and wrong product, disintegration/dissolution, GMP non-compliance and transport/storage.

10.2. Medical device recalls

Table 57 Medical device (including IVDs) recalls by reason for recall
  2015-16 2016-17
July to June
Reason for recall
Adverse incidents 6 7
Diagnostic inaccuracy 82 105
Electrical defect 49 28
Illegal supply 0 2
Labelling and packaging 119 89
Mechanical and physical defects 173 169
Software defects 135 109
Sterility 3 14
Othera 44 75
Total 611 598
  1. 'Other' includes bioavailability, disintegration/dissolution, microbial contamination, variable content, foreign matter, impurity, wrong product, therapeutic inefficiency and observed differences.

10.3. Biological recalls

Table 58 Biological recalls
  2015-16 2016-17
July to June
Recalls to hospital level 0 2

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