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 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. 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 safety issues. The recall is an effort to limit liability for corporate negligence (which can cause costly legal penalties) and to improve or avoid damage to publicity. Recalls are costly to a company because they often entail replacing the recalled product or paying for damage caused by use, although possibly less costly than consequential costs caused by damage to brand name and reduced trust in the manufacturer
Safety (or other) problems which justify product recall may be such that they relate only to a single manufacturing batch identifiable by number (e.g., microbial contamination of an intravenous fluid due to a machine fault) or to an entire product. In both cases, the duties which law and ethics impose on the manufacturer will be similar:
a. To cease at once to supply the product or batch concerned
b. To warn the health professions immediately to stop further prescribing, dispensing and intake of the material, providing reasons for the warning
c. To warn the public with appropriate urgency and prominence to return the product to the pharmacy or retailer and (in case of prescription product) to ask the physician for an alternative prescription
d. To collaborate closely with public health authorities so as to ensure that the measures taken are appropriate and efficient
Category of Drug recall:
A drug recall occurs after the Food and Drug Administration receives numerous adverse reaction reports from physicians in regards to a particular drug, or after the manufacturer realizes that there was a deficiency in their manufacturing process. To put it simply, a drug recall removes the affected prescription or over-the-counter drug from the market. Generally, a recall must be warranted by the high likelihood that the drug will cause extremely serious injury or death. While all drug recalls are not to be taken lightly, the FDA classifies them as Category I, II or III.
Category I: The use of, or exposure to, the recalled drug is most likely capable of causing a serious health issue or even death to the consumer.
Category II: The use of, or exposure to, the recalled drug is not likely to cause a serious health issue. At most, it may cause temporary or medically reversible adverse health consequences.
Category III: The use of, or exposure to, the recalled drug is not likely to cause an adverse reaction
