I would definitely agree on a recall because it will be the company's fault if one of their product device harms a person. The company is responsible of displaying all warning, healthy issues because the product they released, the public might have a little to no information. For example, if their is a new drug to relieve headaches faster, everyone will just consider it another drug to relieve headaches but it could be harmful to diabetics, which no one knows. Recall is required and an investigation must be conducting because this flaw should not have happen, it could of cost the company a large sum of money. The company will need to regulate a better function production.
I would agree with the reviews above which thinks that a product with a peeled off label or similar defects should still be recalled as they may lead to a severe dangerous consequence in some cases. For example, a pain relief medicine that is unsafe to be used by a pregnant woman (such as Aspirin, Ibuprofen, Herbs, minerals, etc.) and the content label or ingredient label was not clear enough to show that important information to the patient. In this case, the label could have prevented a risk for the mother and the baby and I think a safety recall should be required.
This can be applied to any medical device or anything related to human health as any information is essential and needed by the user and the market and labeling approval by the FDA should be reviewed.
I found an interesting link related which is an example of this topic regarding "Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up"
https://www.fda.gov/Safety/Recalls/ucm618583.htm
Part of the FDA requirements is that labels and markings have to be correctly placed on the device. They have to be visible and clear for the user. If they're not, then they're breaking FDA compliance and must order a recall. One article said: "In July 2014 alone there were 143 recalls due to labeling issues, 94 of which were food products. The labeling issues included improper claims, such as claiming to be organic, and missing or incorrect required information like instructions, ingredients, and expiration dates. FDA label requirements can be complicated. Registrar Corp can revise your food, drug, medical device or cosmetic label to comply with U.S. FDA regulations." This makes it clear that the FDA is serious about correct labeling. The company should also be willing to recall the product in the first place because it will show its customers that it is serious about their safety.
Once a product is in the market for the public to use, any unpredictable problems can lead to a recall. However, recalls are always voluntary. Sometimes a company discovers a problem and recalls a product on its own without consulting FDA. Other times the company recalls a product after the FDA raises concerns regarding their product. For any medical and drug product, there is a classification before exporting in the market. Similarly, there is a classification for recalls as well. the Guideline for Class I state any dangerous or defective products that possibly could cause serious health problems or death. Class II defines products that might cause a temporary health problem or a slight threat of a serious nature. Class III defines products that are unlikely to cause any health reaction but violating FDA labeling or manufacturing laws. Therefore, when the labeling is mismatched or incorrectly posted, I think they are required to be recalled by the FDA. And regulated in a proper manner before sending for use in the market.
If the labels kept falling off to the point where customers were filing complaints, the products should definitely be recalled. Even if the product had no other defect and was in perfect working order, the instructions and warnings on the labels are crucial especially when dealing with materials that may cause harm. For example, in a lab setting, all materials used must be properly labeled with warnings about the possible side effects from contact/inhalation/exposure. If the labels happen to peel off often, not everyone at the lab will recall what the vials/beakers contain. It doesn't matter if the product does its job if isn't clear what the product is and how it should be handled. While the hydrophilic coatings mentioned in this week's simulation won't cause direct harm from contact, clients can accidently use the wrong coating due to the lack of label. For example, using the unlabeled bottle of hydrophilic coating when a hydrophobic coating is required.
I think there are different situations with the labeling which could result in either immediate corrective action or even a recall. As we have have heard before, labeling is one of the three core components of what constitutes a medical device so any type of failure to a label can be considered serious. If it's in respect to the labeling perhaps peeling off, that may not be cause for market intervention since the doctor or patient should already be familiar of what it is and how it is used in case it falls off. On the other hand if the labeling contains wording or descriptions which are incorrect or misleading about the product and can result in user injury then it should probably be recalled immediately. While it is not ideal to have faulty products out in the market, certain exceptions should be taken sometimes to avoid the various negative implications of recalls.
Recalls occur when a medical device or product is defective, when it could be a risk to health, or when it is both defective and a risk to health.
More than 60 percent of FDA recalls are due to labeling issues. Most of these errors relate to allergens. Processors inadvertently put the wrong label on products, a change in the ingredients or medical parts doesn’t show up on the label, or the label doesn’t include a complete list of allergens, ingredients, or parts included in the medical device.
That been said, labeling is a big deal. And as some of you have said, it is the product itself. So if the label of a product is peeling off or coming out and before it gets to the customer, essential part of the information is out, this can pose danger to the individual if they are unable to verify if it contains allergens or how the medical device should be used and what to avoid when using it. If any improper or missing code can result in returned, rejected or recalled product how much more a fallen label which is likely to contain ingredients of the product or vital information needed by the customer.
In sum, depending on the danger a product will have on the public or customer, any fallen, peeling or missing label must be recalled and will only be modified going forward if previous batches already in the market does not pose an adverse effect on the customers.
Reference: www.fda.gov
I agree with the responses before me that products should be subjected to FDA recall if there are label errors associated with the product. The product's label is one of the first things that the customer will see before purchasing/using the product. Without the correct label, customers could be led to believe that they are taking a higher or lower dose than they were advised to take. Faulty labels could also result in customers taking a medication past its expiration date. Labels contain important information like ingredients list, dosage strength, expiration dates, batch and lot numbers, instructions for use, side effects etc. The FDA has guidelines and requirements for a product's label for a reason. The lack of any of this information or any misleading information could result in unwanted adverse effects for the customer that could result in serious injury/death.
I believe that if there is information missing from the label of the product, there should be an instant recall. How this even would get past the FDA I'm not sure. However, missing information goes against the standards put forth by the FDA. All product information should be readily available to the customer/user to ensure there is no backlash. Missing info may also allow the user to take a more legal approach to the manufacturer of the product. If, for instance, there happens to only be one defective case, a court case can be made for missing information on the label.
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?
In regards to issues involving missing information or label errors, safety recalls would be imperative because it could directly affect the customer. Most physicians chose a specific product with certain specifications that meet the patients needs. Say we have a product with a specification and the product is mislabeled for a different specification, and if used on a patient, that patient can suffer severe consequences. Most products are chosen by doctors due to the product specification meant for the patient. And for that reason, to recall all products and correcting the error made would preventing any possible negative through requiring all products released to be brought back to the manufacturer. In response to the recall, a company would then work on improving their production methods.
A product with missing or a peeled off label would cause a recall as the label contains the information about the drugs on it. It is very important for the patient or the user to know what they are using to be safe from any allergies or side effects. If the product is not recalled it might cause some problems to the users and that would be a downfall to the company. The production ways should be improved in order to stop these minor mistakes and deliver a product successfully.
One of the FDA’s purposes is to ensure the safety and efficacy of medicine. This includes when the product is already on the market. One of the issues of a product on the market that needs to be faced is proper labeling. If a product is improperly labelled it can be hazardous it will lead to improper use. Considering that the FDA does not allow products on the market it seems dangerous, a product that is mislabeled would have to be recalled. To be allowed back on the market, the company would need to prove to the FDA that the production method was approved such that the labels are no longer defective.
I wouldn't think such issue or failure would require a recall. Recall is defined by the FDA as when when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. The product would still performed as described and desired regardless of the label sticking or not. The information on the label is of course important to the patient or the user, however, those information can be found online or simply if the label peels off when purchasing you can easily avoid purchasing that specific bottle and move to the next one since after purchasing the bottle there is no value of the label since you already know the concentration and the volume of the bottle when you bought. I think a smart corrective action would be color coding the bottle for the different volume and concentration to be able to differentiate them. The company should still capture those failures and complaints and work on making changes to the product and update the FDA through a new submission not through a recall.
Before I answer the question asked I think its important to remember the actual reason why Labels were introduced for medical device. The two main important reasons as to why we are supposed to put labels is to ensure that the products are used according to the manufacturers instructions and also to protect the manufacturer form court case if the product is used "off-label", i.e in a way other than for what it was intended for.
To answer the question I asked, I think they company should do both. First thing is to improve the adhesive on the label so it sticks or change the label type. As I said before, labels even though may not seem important to the actual use of the product however the provide vital information needed to correctly use the product for what it is intended for. Like the EU(MDR), I hope the FDA also takes the next step to improve the labelling requirements to included IFU's or an EIFU. In the example given the product isn't risky however if the company is not cautious right now regarding such cases, in the future they can loose the trust of their customers and potentially have a business impact.
The response provided might seem a bit extreme however, such labelling scenarios are very frequent and if they are not taken seriously they can raise many red flags.
In my opinion safety recall of released products is determined by many factors like a defect or test failure leading to major events such as death or morbidity. In case of label peel of in products contains chemicals or medicine I would force a recall but if the label peel off of known product such as food cans I would suggest a modification in furtherer production for those products.
