Recall No : | PR070046 |
Date : | 11 December 2007 |
Name of Product : | Biflora Brand Fufang Danshen Pian (film-coated) [双花牌复方丹参片薄膜片] |
Batch No : | 051104 |
Pack Size : | 0.35g x 60 tablets/bottle |
Class of Recall : | 2 |
Level of Recall : | Retail |
Product Reference No : | 113767 |
Local Company : | Ban San Tong Koong Kee |
Manufacturer : | Hefei Shenlu Double Crane Pharmaceutical Co. Ltd |
Country of Manufacture : | China |
Reason for Recall : | Contained arsenic above the permissible limit of 5ppm |
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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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