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FDA recalls drugs for preventing products liability

Products liability is defined as the responsibility that the manufacturer or producer of a product takes in order to ensure that the consumers of a product are not adversely affected due to negligence of the producers. Products liability is thus based on the principle of negligence enshrined under the common law principles of tort law.

Recently the Federal Drug Administration, or FDA, asked a medicine firm to recall pharmaceutical drugs from the market. The FDA has the statutory authority to recall defective prescription drugs from the market if any defect is found in the medicinal products or drugs. It has been suspected that the drugs recalled have been on grounds of the Class I prescription drug recall.

Prescription drug recalls may be ordered by the manufacturer itself. Sometimes the FDA authorities themselves ask the drug company to recall their drugs. Such recall may also be initiated by FDA under its statutory authorities. Some prescription drugs may be withdrawn from the market which has, in some way, violated rules laid down by the FDA guidelines. Medical devices and products that have been suspected of some defect may also be alerted to the public as hazardous.

Prescription drug recalls are placed into one of three categories:

  • Class I category of recall of prescription drugs is given for drugs, which the authorities have found reasonable cause to suspect that the product has been exposed to some product that can be hazardous and cause health hazards to the consumers.
  • Class II of prescription drug is given for those products which have been recalled on grounds of being exposed to such hazardous substances that may cause temporary and reversible health hazards.
  • Class III prescription drug recall is issued for such prescription drugs which have been exposed to substances which may not cause any hazardous heath problems.

Source: FDA.gov, "Drug recalls," accessed on Dec. 4, 2014

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