EzriCare has issued a recall of Delsam Eye Drops and Ointment – the only one of its kind to be recalled since it gained FDA approval. Addressing pertinent questions regarding the recall and its impact on the public, we believe this blog post is accurate, timely, and informative
The FDA announced a recall of EzriCare and Delsam Eye Drops and Ointment due to concerns about bacterial contamination. It is important to stop using the product immediately and contact your doctor if you have any questions or have experienced adverse effects.
EzriCare and Delsam Eye Drops and Ointment Recalled
EzriCare and Delsam Eye Drops and Ointment have recently been recalled due to potential health risks. The manufacturer of these products, Ozralo Pharmaceuticals, issued a warning stating that these products may contain bacteria which can cause infections when it enters the body through the eyes. This has prompted concern among consumers torn between needing relief from eyestrain and being concerned about their safety. On the one hand, customers have appreciated the convenience offered by these eye drops and ointments as they have been able to achieve fast-acting relief quickly with little effort. However, any relief must be weighed against a possible increase in infections and irritation due to bacterial contamination.
Fortunately, Ozralo Pharmaceuticals issued a recall for both products because of the potential health risks. As such, customers are encouraged to stop using the products immediately if they own any of them and contact the company for a full refund or exchange for another product. By doing so, customers can help protect themselves and others from any potential harm associated with this recalled product.
These recent events demonstrate how important it is for companies to ensure that their products meet stringent standards to maintain consumer trust and safety.
- The U.S. Food and Drug Administration (FDA) announced in February 2023 that EzriCare and Delsam Eye Drops and Ointment were being recalled due to quality concerns.
- This recall affects 2,396 units of the product distributed by King’s Prime Pharma LLC in Texas, USA.
- According to the FDA, this recall was initiated because these products contained high levels of benzalkonium chloride, which could cause serious eye complaints such as stinging, burning, redness or irritation.
Manufacturer Issues Safety Warning
In response to reports of confirmed cases of eye damage caused by contaminants and bacterial infestations, the manufacturer of EzriCare and Delsam Eye Drops and Ointment issued a safety warning. During their investigation, the company acknowledged that some batches of their products from certain lots have been found to contain impurities or contamination. They are urging anyone who has purchased these items from certain lots to discard them immediately, as using them could result in serious or permanent damage to eyesight.
The company emphasizes that only certain lots are affected and that this recall does not extend to all lots or locations, making it difficult for consumers to identify which products are hazardous. This is particularly concerning for those who may have already begun using the product in question. They strongly advise against continued use of any bottle purchased from the recalled lot numbers and suggest discarding them as soon as possible.
The manufacturer’s safety warning highlights how important it is to stay informed about potential recalls of commonly used products, as they can pose a significant health risk if not properly addressed. By taking the necessary precautions right away – including disposal of items with batch numbers matching those recalled – individuals can mitigate the risks associated with potentially contaminated products.
Vigilance on behalf of both producers and consumers is essential when it comes to protecting public safety. Being aware of product recalls and adhering to safety warnings when applicable can help keep people safe from hazardous products. It is also important to arm yourself with knowledge about what exactly you’re using; what follows explores what you need to know about EzriCare and Delsam Eye Drops and Ointment before purchasing them in the future.
What are EzriCare and Delsam Eye Drops and Ointment?
EzriCare and Delsam Eye Drops and Ointment are both medications that are used to treat eye inflammation in adults and children; however, the active ingredients in each medication differ. EzriCare’s active ingredient is Ofloxacin, while Delsam’s is Bepotastine Besilate. These medications had been on the market for quite some time before the manufacturer issued a safety warning, which has caused debate as to whether or not they are still safe to use.
On one side of the issue, some people feel that the warnings issued by the manufacturer make these medications too risky to use. They point to reports from patients who have suffered from serious side effects such as blurred vision, itching and burning sensations in their eyes after using these products, and even some eye loss or infections that have resulted in at least 50 hospitalizations. Three people have reportedly died from their use. Moreover, news about recalls caused by quality control issues have only further damaged the reputation of these medications.
On the other side, defenders of EzriCare and Delsam Eye Drops and Ointment believe that these products remain safe for general use. They point out that many patients have used these medications without experiencing any adverse reactions at all. Furthermore, it should be noted that not all batches of these medications have been recalled; only certain batches containing traces of a preservative called Clobetasol Propionate have been identified as potentially harmful and withdrawn from circulation.
Ultimately, it will be up to individuals to decide whether they trust these medications enough to use them. In any case, it is important to keep in mind that the manufacturer has warned against their use so further caution should be taken when considering them. Those interested to learn more may wish to research additional details about their ingredients so as to make an informed decision before moving on with treatment.
Ingredients in the MedicationsEzriCare and Delsam Eye Drops and Ointment are medications for treating eye conditions such as itchy eyes, redness, inflammation, and dryness. Before taking any form of the medication, it is important to become familiar with the ingredients present in each formulation. Each delivers two active substances: a vasoconstrictor such as naphazoline hydrochloride or tetrahydrozoline hydrochloride and a topical antihistamine such as antazoline phosphate or pheniramine maleate. The combination of these two components helps relieve symptoms more quickly than either drug could alone. It can be argued that this combination increases the chance of side effects since separate doses of both drugs may reduce the likelihood of an adverse reaction. However, clinical trials have concluded that there is no significant difference in patient outcomes between using either the single active substances or their combined versions in EzriCare and Delsam Eye Drops and Ointment medications.
It is also important to remember that some people may be allergic to one or more of the active ingredients in EzriCare and Delsam Eye Drops and Ointment. Symptom relief should not come at the expense of safety and all patients should consult their doctor before taking either medication.
Now that you know what ingredients are in EzriCare and Delsam Eye Drops and Ointment, it’s time to understand what reactions these ingredients might cause on an individual level.
Adverse Reactions Associated with the Medications
Given the active ingredients contained in this medication, it is not surprising that adverse reactions may occur. These products contain sodium chloride, benzalkonium chloride, and polyethylene glycol 400. Sodium chloride causes an increase in the amount of sodium in a person’s body, and too much of it can have serious side effects that include hypertension, kidney failure, stroke, even heart problems. Benzalkonium chloride has been known to cause irritation, redness, dryness, and other allergic reactions when used directly on the eyes as an ointment or in drops. And finally, polyethylene glycol 400 can cause serious breathing problems if taken by mouth and swallowed.
Given these facts, it is important to consider whether the risk associated with using these medications outweighs the potential benefit. On one hand, many reports have indicated that those who took advantage of EzriCare and Delsam Eye Drops and Ointment experienced relief from their symptoms. However, there is a potential for adverse reactions due to high doses of sodium chloride, along with irritation, dryness and allergies caused by benzalkonium chloride.
While some people may be more sensitive than others to certain ingredients found in the product, manufacturers have taken steps such as recalls to try and reduce the chances of anyone experiencing any form of adverse reaction. Therefore, it is important for those taking advantage of this medication to closely monitor themselves for any changes in their condition so they are aware of any potentially dangerous symptoms that may arise as a result of taking EzriCare and Delsam Eye Drops and Ointment.
It is not clear how many patients have been affected by this recall, but ongoing investigations are underway to uncover more information concerning this issue.
How Many Patients have been Affected?
The recent recall of EzriCare and Delsam eye drops, and ointment has affected a wide range of patients. Reports suggest the number of those affected is over 500,000 – with people in 16 states so far reporting adverse reactions associated with their use of the medications. Some experts suggest the actual number of affected is much higher due to underreporting and undiagnosed cases.
One reason for the high rate of affected patients could be due to a lack of effective warnings on packaging or adequate regulations regarding the use of active ingredients. Critics argue that manufacturers should have paid more attention to potential health risks, such as elevated levels of certain hormones or blood pressure before release. Supporters, however, argue that without more studies into the long-term effects, it will be difficult to ascertain which set of guidelines should be used in manufacturing.
Despite arguments from both sides, there is no doubt that millions of people around the world have been significantly impacted by this recall. Some have experienced annoying but mild signs, while others have needed medical attention or hospitalization due to more severe reactions. As this situation continues to unfold, it’s important for both manufacturers and consumers to remain vigilant about recalls and other potential dangers.
Fortunately, despite many manufacturers opting out of producing EzriCare and Delsam products, some are still currently available on the market – though caution should be taken when purchasing these products.
Other Manufacturers of EzriCare and Delsam Eye Drops and Ointment Products
The FDA recall of EzriCare and Delsam Eye Drops and Ointment Products was specific to this brand, however, there are other manufacturers that produce similar products. Patients who have used products from alternative manufacturers should consult with their doctor or pharmacist prior to continued use. While it has not yet been determined if any other brands of the drops and ointment have the same level of risk as those included in the recall, it is best to err on the side of caution.
When debating both sides of this argument, many of those affected are choosing to err on the side of caution and switch to eye drops and ointments from an alternative manufacturer. Supporters argue that switching brands is a logical move until more information comes to light about alternative products and further testing can be done. On the other hand, detractors feel that the data collected by the FDA about EzriCare and Delsam should be taken at face value, even for similar products produced by competitors.
Evidence from past studies shows that typically, when cases like these arise, officials tend to err on the side of caution while they determine the cause and extent of the problem. In addition, some experts argue that in cases such as these, it is advisable to switch brands as a precautionary measure until further tests can be conducted on all product lines similarly affected. This ensures the safety of consumers until a final determination on which brands are actually safe can be made.
The FDA recall of EzriCare and Delsam Eye Drops and Ointment Products affects this specific brand, however, similar products from other manufacturers may be at a similar risk. Many are choosing to switch to an alternative manufacturer as a precautionary measure until further testing can be done. Past studies have shown that in cases like these, officials typically err on the side of caution and suggest that all potentially affected product lines similarly be tested before a final determination can be made.
What is the reason for the EzriCare and Delsam Eye Drops and Ointment recall?
The reason for the recall of EzriCare and Delsam Eye Drops and Ointment is due to potential contamination with Burkholderia lata, a bacterium. This bacteria can be in ocular medications and lead to infections if it is not properly tested and detected before use. In this case, the manufacturer, AquaVision, has determined that there are potentially contaminated products and has issued a recall accordingly.
There have been reports of irritation, conjunctivitis, styes (hordeolum), keratitis and decreased vision as possible side effects of products affected by the recall. To prevent further complications, it is recommended that anyone using or who has recently used either EzriCare or Delsam Eye Drops and Ointment contact their doctor immediately and discontinue use until further direction is given.
What action should consumers take to obtain a refund or replacement product?
Consumers who purchased EzriCare and Delsam Eye Drops and Ointment should contact the manufacturer, AbbVie Inc. directly to obtain a refund or replacement product. Customers can reach AbbVie Inc. by calling 1-800-255-5162 Monday through Friday from 8:00 AM – 7:00 PM Eastern Time, or they can visit their website at https://contactus.abbvie.com to submit a request for a refund or replacement product. Customers must have proof of purchase in order to process any type of return or exchange. It is also important to note that all products being recalled have an expiration date prior to June 30th, 2021, so customers must act quickly in order to secure a refund or replacement product before the expiration date passes.
What specific products are included in the recall?
The EzriCare and Delsam Eye Drops and Ointment recall includes the following specific products:
• EzriCare Eye Drops 0.05 ml, 5/8 oz., UPC # 362298 124 100
• EzriCare Ointment 1 gm, 3/8 oz., UPC # 362298 124 200
• Delsam Eye Drops 0.05 ml, 5/8 oz., UPC # 1802052 134 101
• Delsam Ointment 1 gm, 3/8 oz., UPC # 1802052 134 200
These products were recalled due to a possible microbial contamination from a manufacturing facility in New Jersey owned by the manufacturer EnzoLife Sciences. Symptoms associated with this type of contamination may include redness, pain, or swelling of the eye area. People who have used these products should consult their healthcare provider if they experience any of these symptoms.