Recall No : | PR070009 |
Date : | 23 April 2007 |
Name of Product : | Axcel Lignocaine 2% Sterile Gel |
Batch No : | B0605040 |
Pack Size : | 20g/tube |
Class of Recall : | 2 |
Level of Recall : | Retail |
Product Licence No : | SIN10517P |
Local Company : | Kotra Pharma Marketing |
Manufacturer : | Kotra Pharma (M) Sdn Bhd |
Country of Manufacture : | Malaysia |
Reason for Recall : | The content of Lignocaine HCI was found to be understrength |
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Class of Recall Class 1 recall is initiated when the product defect poses a life-threatening situation to users. Some examples of defects that will result in a Class 1 recall are non-sterile injections, contamination with toxic substances and products with major labelling errors. Class 2 recall is initiated when the problem or defect is unlikely to cause serious harm to users. Some examples of defects that will result in a Class 2 recall include products with minor labelling errors or products which fail to meet product specification or pharmacopoeia standards but are likely to cause minimal hazard to users. |
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