The discussions that we have been having this week around test failures and untested medicine lead me to start thinking about failures in the product that are identified. When a defect is identified for released products, the company will need to submit the recall to the FDA. My question is whether a recall would need to be submitted for issues involving missing information or label errors, even if there is no issue with the product itself. If the labels from our simulation were peeling off in the field to the point where there were many customer complaints, would the company want to recall them or just work on improving production methods?
https://www.fda.gov/safety/recalls/industryguidance/ucm129259.htm
I would say that even if the product itself is okay, something such as missing information on a label can still force a recall. If, for example, a drug label is missing an ingredient and a patient taking that drug has is allergic to said ingredient, this poses a series health issue. The example of the label falling off is much less extreme example but I believe it would still force a recall. The label is an essential part of many products. But more importantly, in the simulation the label itself was the product. If label was no longer staying on the bottle than the whole product can be considered faulty.
I don't think that an issue such as labels peeling off of the bottle when submerged underwater, would be enough to warrant a recall but the company would still likely respond if many customers were having complaints. Having a label peel off the bottle may be an inconvenience or annoyance, but it doesn't have an affect on the safety of the drug inside the bottle. Rather than have a recall I could see that company modifying the way that they place the labels onto the bottles in some way.
I do believe the label is just as much a part of your product as any other aspect. If a label falls off and a product is used incorrectly a company could be liable for leaving the consumer unaware of proper use. If this failure of use causes death or injury your company could fall to blame for not clearly labeling. When a product is not working correctly in anyway it should be recalled. Many companies will try to leave their product on the market for fear of losing the financial cost of the product. If an issue occurs the cost will be higher than the recall and the damage to the brand name could ruin a company. The failure to recall has hurt companies in all markets and should be even more heavily followed in the medical field.
I agree with the answer posted above that a recall would not be take place with faulty adhesive on labels as it does not have an affect on the safety of the contents inside the bottle. Mislabeling however would be grounds for a recall as the ingredients must be accurate. in the case of a poor adhesive causing customer complaints, the company would likely implement the appropriate changes to ensure proper adherence for all future merchandise.
I agree with @williamzembricki and @rjs84 that label is crucial and if something happens to the labels that just as important as the product. In some cases FDA requires a certain font to make sure the user can read and understand the directions on the label. I think having a problem with labeling on a product especially a device or drug would warrant a recall. The user has to be able to clearly read the label and all of the pertinent information. Here is PDF document of the CDRH Labeling Regulatory Requirements for Medical Devices:
This is what medical device companies should implement for labeling.
Labeling and packaging of product pay a great deal of attention to ensuring compliant with good manufacturing practices (GMPs) and FDA regulations. The manufacturers can’t afford to ignore errors in product labeling or packaging artwork or missing information. Mislabeling can cause misuse of product leading to serious effects. However the cost of recalling a product due to mislabeling or packaging defect can be substantial but it can cause great damage to company image and customer satisfaction . The peeled off label can cause recalling of medicine because of confusing dosing instructions. Mislabeled product sometimes doesn’t do what it says on label for example you are taking a pain reliever based on the package material, when in fact inside the box is something else.
I think the label and the information on the product is very important for the patient as patients normally read it carefully before consuming it or using it. So, I think it is better to recall the product from the market because the missing information or the error in the label may be important to the patients who are going to use it. Since both the things information and the label is important as the patient may be allergic to the missing ingredient so may for the safety of the patients it is better to recall the products.
In terms of labeling mishaps, there are two criteria that should be considered: The adhesive property of the label to the product container as well as the content of the label itself. Reading the comments above, not much importance seems to be given to the adhesive property of the label. I believe that aspect of labeling is just as important as the content of the label. Aside from the inconvenience and the annoyance that a faulty adhesion might incur, the patient might miss a piece of information ( perhaps because the label fell off the bottle and got lost) which could have an advert effect on their health. Let's say, the label can easily come off via scratching on contact with water, and consequently instead of reading " hydroxyquinone", the label now reads "hydroxyquino--". Perhaps, the word that immediately comes to the patient mind is "hydroxyquinoline", which is fundamentally different from the above-mentioned compound. Knowing that the patient is allergic to "hydroxyquinone", but not " hydroxyquinoline", the patient might wrongly take the drugs and ultimately put his/her health at risk.
This example might seem to elaborate but, the scenario is quite plausible which is why I believe the adhesive property of the label shouldn't be overlooked.
I do not believe that a faulty label on a batch of drugs would cause for an entire recall of the product as that would be extremely expensive for the company. Instead I believe the company would release a large statement explaining what happened this faulty labeled batch, and that anyone who receives their product should double check on the website that it is the correct drug. From there on the company should cease production until the small label error can be fixed. If someone is already prescribed to these drugs then there should be no worry of allergies. Also, most prescribed drugs are given a secondary label from their doctor detailing how and when to use the drug. However, if this is a store bought product and not OTC, a label defect may cause a large hit in sales for the company. I know personally I never buy something off the shelf with a missing label, especially medication. I do not believe that a faulty label would be a cause for a recall. Instead this would just warrant the company to create better production methods so that this incident does not keep occurring. The only reason that a recall should be necessary is if the product is killing, or making people sick.
I think that a recall on a product with a faulty label depends on the product itself. For example, makeup products have ingredients that have to be approved by the FDA, if a makeup product has a faulty label I do not believe that a recall is necessary because using the makeup incorrectly will not cause any severe damage to the consumer. However, dealing with a product like over the counter medicine, prescription drugs, or anything that has a set of physician instructions on how to use then the label is important because there are dangers that come with using these products incorrectly.
It makes sense that if there is a defect in the labeling of a product resulting in mass amounts of missing labels, that an easy solution could be to remedy the problem for future sales, and simply inform anyone who has received/purchased the medicine to check the dosage and usage directions online before using. But for the 99% of people who do this and use the product exactly as intended, there will always be people who use it wrong. It even happens when the label is perfectly intact right on the bottle. If the label is not on the bottle due to a fault of the production company, they could be liable for any problems caused by misuse of their product due to a failure to inform consumers of the safety requirements. If the medicine is something like over the counter seasonal allergy medicine, I could see this not being a problem big enough to warrant a total recall due to the very low likelihood of serious injury. However, if the issue is with a more potentially dangerous product such as prescription pain medicine, there is a much greater need for a total recall. The issue and question I have is where is that line drawn? What is the criteria for a product to warrant a total recall due to a labeling mishap?
A missing or erraneous label means that the product can not and should not be used. FDA regulation is strict for a reason. If anything is wrong with the product people can become very sick or die. The amount of money lost due to a recall is nothing in comparison to the worth of the patient. For most drug companies, those that put people first usually have profits follow. When dealing with patients, a missing label or mislabeled product is too much of a risk to take . When it comes to medicine, most people stick to absolutes (it's either we absolutely know it's the product and we know the risks or it's not).
I think that this would depend on the information on the labels of the products. If there were important safety information or details regarding use, then the product should be recalled because customers will complain about the product if it causes problems or fails to perform as expected. I don;t believe that the answer is one or the other, the company/firm should focus on improving it's production methods and do a recall on the product only if the information on labels is important for customers who use the device. If the device just gives details regarding the device, then a recall should be issued. However, if the information is important for safety and preventing serious injury to customers, then it should be recalled. As previously mentioned, customers will complain about the product if the product doesn't work or causes serious injury. If serious injury or harm could've been prevented by the information on the labels or warning stickers, then it's should be recalled and the financial losses should be taken as medicine. Recalling the products would help prevent consumer confidence in the company from going down to a marginal level. If the company doesn't recall products, then consumers may think that the firm exists to scam people out of their money.
I think if there is a problem with the labels stating useful information about the product then the product should be recalled as labels help in assisting the customer about the proper handling of the product as well as if the safety label information of the product is not in place then it needs to be recalled as the operator would not know how to handle it and could cause damage to either the operator or the patient and that would create a big issue as the reputation of the company would take a hit also the share cost would be affected thus, loss to the company. One such example where a company's reputation was hit that is somewhat related to the topic is that of Johnson & Johnson's talc powder where reports suggested that it contained asbestos which can cause cancer, the stock price of Johnson & Johnson tumbled by 10%, losing $40 billion of its market value.