Which classification of drug recall could cause a temporary health problem or slight threat of serious harm?
Class II: A product that might cause a temporary health problem, or pose slight threat of a serious nature.
Which classification of recalls indicates a product may cause temporary but reversible side effects or little likelihood of serious adverse effects?
Class II recalls refer to drugs that induce temporary and/or medically reversible health effects. Class III recalls occur when adverse health effects are not likely to occur when consuming the drug or being exposed to it.
What type of hospital error occurs when a medication is compounded incorrectly and administered to the patient?
A mechanical error is a mistake in dispensing or preparing a prescription, such as administering an incorrect drug or dose, giving improper directions, or dispensing the incorrect dose, quantity, or strength.
Which of the following is the most urgent and serious type of drug recall?
A Class I recall is the most urgent and serious of the three types of FDA recalls. Class I recalls usually pertain to defective products that can cause serious health problems or death. An example would be an over-the-counter medication that has contamination from a toxin.
What are the three classes of drug recalls and their descriptions?
Recall Classifications Class I: Recalls for products which could cause serious injury or death; Class II: Recalls for products which might cause serious injury or temporary illness; Class III: Recalls for products which are unlikely to cause injury or illness, but that violate FDA regulations.
What should you do if you own a product that was recalled?
Typically, the instructions will indicate that you need to do one of the following:
- Return the product to the store where you bought it for a refund.
- Dispose of the product properly so that other people or animals cannot eat it. (This is particularly important if you opened the product.)
What are 3 possible reasons for food recalls?
Top 3 Reasons For Food Recalls
- Cross Contamination. Many food manufacturers process multiple products in a single factory.
- Pathogens. Recalls from pathogen-contaminated products are highly damaging because they affect all consumers, not just those with specific allergies.
- Physical Contamination.
Who is responsible for product recall?
Food & Drug Administration (FDA) – The FDA is responsible for ensuring the safety of food, tobacco products, dietary supplements, pharmaceutical drugs, medicines, medical equipment, cosmetic products and veterinary products. Recalls of products in those categories fall under the domain of the FDA.
Do Product Recalls expire?
Product recalls usually don’t have an end date. If you don’t find out about a recall for a year or more, follow the instructions in the recall notice the CPSC issued.
How do product recall affect an organization?
The company or manufacturer absorbs the cost of replacing and fixing defective products, or of reimbursing affected consumers. Recalls can tarnish a company’s reputation and can lead to multi-billion dollars in losses.
Why is the market withdrawal of a distributed product is not subject to legal action by FDA?
A market withdrawal is a firm’s removal or correction of a distributed product for a minor violation that would not be subject to legal action by the FDA or that involves no violation (e.g. normal stock rotation practices, routine equipment adjustments, repairs, theft, etc.).
Can the FDA mandate recalls?
The FDA continues to rely on responsible parties to voluntarily recall violative food products; however, FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met.
How long are drug recall notices?
The retention period shall be no less than five years after the records of manufacture have been completed or six months after the latest expiration date for the individual product, whichever represents a later date. (2) Records of recall.