Recall No : | PR070002 |
Date : | 15 January 2007 |
Name of Product : | Pilsol Capsule |
Batch No : | 818 |
Pack Size : | 10 capsules / strip |
Class of Recall : | 2 |
Level of Recall : | Retail |
Licence/Reference No : | Not applicable |
Local Company : | Century 10 Ayurvedic Therapy Pte Ltd |
Manufacturer : | Shankar Pharmacy |
Country of Manufacture : | India |
Reason for Recall : | Contained mercury and lead above the permissible limits of 0.5 ppm and 20 ppm respectively |
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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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