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Annual performance statistics report: July 2018 to June 2019
Print version
21 October 2019
11. Recalls
11.1. Medicine recalls
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Number (% of Total) | ||
| Reason for recall | ||
| Adverse reactions | 1 (3%) | 2 (5%) |
| Foreign matter | 5 (14%) | 5 (12%) |
| Illegal supply | 2 (6%) | 2 (5%) |
| Impurity and degradation | 1 (3%) | 4 (10%) |
| Labelling and packaging | 8 (23%) | 14 (34%) |
| Micro-organisms | 1 (3%) | 2 (5%) |
| pH | 0 | 0 |
| Potency | 3 (8%) | 1 (2%) |
| Sterility | 1 (3%) | 0 |
| Other[a] | 13 (37%) | 11 (27%) |
| Total | 35 (100%) | 41 (100%) |
Footnotes
| [a] | 'Other' includes dissolution, physical defects, observed differences, variable content, diagnostic inaccuracy and wrong product, disintegration/dissolution, GMP non-compliance and transport/storage. |
|---|
11.2. Medical device recalls
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Number (% of Total) | ||
| Reason for recall | ||
| Adverse incidents | 3 (0.5%) | 5 (0.8%) |
| Diagnostic inaccuracy | 3 (0.5%) | 66 (11%) |
| Electrical defect | 41 (7%) | 23 (4%) |
| Illegal supply | 2 (0.4%) | 1 (0.2%) |
| Labelling and packaging | 14 (2%) | 131 (22%) |
| Mechanical and physical defects | 202 (37%) | 203 (34%) |
| Software defects | 97 (17%) | 130 (22%) |
| Sterility | 5 (1%) | 3 (0.5%) |
| Other[a] | 187 (34%) | 34 (6%) |
| Total | 554 (100%) | 596 (100%) |
Footnotes
| [a] | 'Other' includes bioavailability, disintegration/dissolution, microbial contamination, variable content, foreign matter, impurity, wrong product, therapeutic inefficiency and observed differences. |
|---|
11.3. Biological recalls
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Recalls to hospital level | 25 | 29 |