Recall No : | PR070039 |
Date : | 9 October 2007 |
Name of Product : | Stada Uno 30 |
Batch No : | 007 |
Pack Size : | 14 film coated tablets/box |
Class of Recall : | 2 |
Level of Recall : | Retail |
Product Licence No : | SIN12195P |
Local Company : | IDS Pharmaceutical Division |
Manufacturer : | MIPHARM 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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