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Journal :   Research Journal of Pharmacy and Technology

Volume No. :   4

Issue No. :  9

Year :  2011

Pages :   1333-1339

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Pharmaceutical Product Recall: An Overview for Handling and Decision Making



Address:   E. Gopinath*, R.S. Bhadauria and Arpit Jain
Shrinathji Institute of Pharmacy, Upali oden, Nathdwara, Rajasthan-313301
*Corresponding Author
DOI No: Not Available

ABSTRACT:
A drug product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of consumer safety issues. Recalls are costly to a company because they often loss their company name form the consumer. The reason for drug product recall is may be due to wrong drug , unapproved drug, Undeclared drug ingredient, microbial contamination in the formulation, Incorrect usage information on package, May contain particulates prior to expiration date, May contain visible particulates etc,. So Products on the market that are suspected or known to be seriously defective and/or pose a potential risk to patient health must be recalled. This must be done promptly, comprehensively and in accordance. This article provide information regarding to Handling and Decision making of Recall Products in Pharmaceutical Companies and guidelines to heath care systems, hospital to handle the recalled drug products.
KEYWORDS:
Drug, Drug recall, FDA, Federal Food and Drug and Cosmetic Act, Recall in hospital, Pharmaceutical companies.
Cite:
E. Gopinath, R.S. Bhadauria, Arpit Jain. Pharmaceutical Product Recall: An Overview for Handling and Decision Making. Research J. Pharm. and Tech. 4(9): Sept. 2011; Page 1333-1339.
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