PR Product recalls and product defects

 

PR  Product recalls and product defects

 

Events

2007

2008

2009

Class 1 (critical)

0

0

0

Class 2 (harmful)

0

1

0

Class 3 (minor)

7

6

9

Class 4 (other defect)

1

2

2

Product recalls total

8

9

11

 

 

Defects identified in medicinal products are classified to critical, harmful or minor, depending on the degree of severity.

  • Class1 (Critical): product defects that are or may be life-threatening or pose a serious health hazard to users.
  • Class2 (Harmful): product defects that are or may be harmful to the users or may affect medical treatment, but which are not included in Class 1.
  • Class 3 (Minor): product defects not likely to pose a significant health hazard to the users, but where removal of the defective product from the market is otherwise justified.
  • Class 4 (Other defect): product defects which are not harmful and there is no need to recall defected products due to safety reason.

Orion has not had any product defect incidents in Class 1 (Critical). In 2008, Orion recalled a batch of Thyroxin tablets from the Finnish market because two packages were found to contain tablets that were heart failure drug digoxin. The incident was classified as a Class 2 (Harmful) incident.  After the incident, Orion inspected the operation of the contract manufacturer of Thyroxin tablets, lowered its classification to conditional and started preparations for in-house production.

In the summer of 2007, Orion recalled its Mixtus cough medicine from the market. This was a precautionary measure because studies with another product revealed that the use of clobutinol, the active ingredient also used in Mixtus, involves a risk of arrhythmia. Mixtus had been available for a number of years and reports on adverse effects contained no similar incidents, but the withdrawal remained permanent and the product has since been replaced by other cough medicines.

A few minor Class 4 (Other defect) product recalls have occurred each year. These have been caused by reasons like errors in the printed packaging material, deviations from the stability values specified, incorrect expiry dates, incomplete packages and leaking dose bags. In these cases, batches have been recalled from wholesalers and pharmacies, but consumers have not been invited to return the products.

 

 

Updated Apr 18th 2011