Recall No : | PR080010 |
Date : | 15 July 2008 |
Name of Product : | Nipin 30 Tablet 30mg |
Batch No : | 8313 |
Pack Size : | 14 extended release film-coated tablets/box |
Class of Recall : | 2 |
Level of Recall : | Retail |
Product Licence No : | SIN11792P |
Local Company : | Zyfas Medical Co |
Manufacturer : | LISAPHARMA S.p.A |
Country of Manufacture : | Italy |
Reason for Recall : | Failed dissolution test |
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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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