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Written by Legal Intern
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Tuesday, 09 February 2010 17:15 |
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The Food and Drug Administration has jurisdiction over recalls involving drugs and vaccines, as well as various other medical devices, products, and biologics. Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
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A Class I recall, the most urgent, is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II is when use of or exposure to a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is the least serious and occurs in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. The FDA also issues market withdrawals on certain products when said products may have a minor violation that would not be subject to FDA legal action (i.e. a product removed due to tampering). A medical advice safety alert is issued under circumstances when a medical device may present an unreasonable risk of substantial harm.
2010 safety alerts for human medical products:
- Alli 60 mg capsules: Counterfeit Product
- McNeil Consumer Healthcare over-the-counter products: recall
- MuscleMaster.com products sold on the Internet as dietary supplements: recall
- Videx/Videx EC: labeling revision
- Infusion Set Needles [manufactured by Nipro for Exelint: recall
- Nipro GlucoPro Insulin Syringes: recall
The FDA issues recalls for products that not only affect consumers, but also health care providers, pharmacists, laboratory managers, and surgical service personnel. Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates. If you have been injured by a defective product or had health issues relating to certain medicines, this should be reported to the FDA and a lawyer from the law firm of Atkins & Markoff should be contacted immediately.
We are consulting and helping people who suffered by using Yaz, Yasmin, Ocella, and Levaquin. If you have any questions or concerns regarding any of the products listed or anything else, please contact our personal injury attorney right now. It is your right to file a claim for the compensation you deserve.
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