Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case!
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Add Photo/Video
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Drugs

Updated: January 24, 2024 1:02 PM
Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. To date, Haleon has not received any reports of adverse events related to this... See More recall.

In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection. In non-immunocompromised consumers, the population most likely to use the product, life-threatening infections are not likely to occur. However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out.

Robitussin Honey CF Max Day and Nighttime are cough syrups indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies. This recall covers only the following lots:
- Product: ROBITUSSIN HONEY CF MAX DAY ADULT 4OZ, Lot Number: T10810, Expiry Date: 31OCT2025.
- Product: ROBITUSSIN HONEY CF MAX DAY ADULT 8OZ, Lot Number: T08730, T08731, T08732, T08733, T10808, Expiry Date: 31MAY2025, 31MAY2025, 31MAY2025, 31MAY2025, 30SEP2025.
- Product: ROBITUSSIN HONEY CF MAX NT ADULT 8OZ, Lot Number: T08740 and T08742, Expiry Date: 30JUN2026 and 30JUN2026.

Haleon is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Consumers who have purchased the product listed should stop consumption immediately.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Haleon
Brand name: Robitussin
Product recalled: Cough syrups
Reason of the recall: Microbial Contamination
FDA Recall date: January 24, 2024

Source: fda.gov
See Less
303


Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. These products were distributed nationwide in the USA to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.

There are... See More corrections in product NDC No for the attached products. Kilitch Healthcare India Limited, is notifying its distributor Velocity Pharma LLC and its distributor Velocity Pharma LLC shall be further notifying the wholesalers and retailers via mail of this voluntary recall and is arranging for return of all impacted products in the list below or the image attached. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return any of the listed products to the place of purchase.

Affected products:
- Product: LUBRICANT GEL DROPS 15 ML. Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V. NDC NO (Wrongly Mentioned in last press release): 11822-9706-5. NDC Nos (Corrected, to be read as) 11822-4540-5. Retailer /Label: Rite Aid.
- Product: LUBRICANT EYE DROPS 15ML (TWIN PACK). Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V. NDC NO (Wrongly Mentioned in last press release): 11822-9707-5. NDC Nos (Corrected, to be read as) 11822-4811-5. Retailer /Label: Rite Aid.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Kilitch Healthcare India Limited
Brand name: Multiple brands
Product recalled: Lubricant Eye Drops & Multi-Symptom Eye Drops
Reason of the recall: Device & Drug Safety Potential Safety Concerns
FDA Recall date: January 22, 2024

Source: fda.gov
See Less
303


Teva Canada Ltd. is recalling a single lot of its Pediatrix Acetaminophen Oral Solution for children due to an increased risk of overdose. The product was distributed nationwide in Canada. The product is available without a prescription and is used to relieve mild to moderate pain and... See More fever in children from 2 to 11 years of age.

The recalled product is marketed under the brand name Pediatrix, and is an acetaminophen oral solution with a concentration of 160mg/5mL. The product is sold in a size/weight of 4 ounces, and the affected batch carries the number MC0079. The product associated UPC is 02027798, with a best before date of August 2025 and DIN 02027798.

The anomaly in the product concentration was discovered through routine testing procedures. It was found that a specific lot of the solution contained approximately 185mg/5mL of acetaminophen, as opposed to the approved and labelled 160mg/5mL. Consequently, if the said lot is used, it could potentially induce an overdose of acetaminophen.

Acetaminophen overdose may cause symptoms such as nausea, vomiting, lethargy, sweating, and loss of appetite. It is important to be aware of this risk as timely intervention is crucial to avoid further complications like liver damage.

If your kid is harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca
See Less
84


Leiters Health is voluntarily recalling 33 lots of products to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. The... See More semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice. The products were distributed nationwide to hospitals for administration in the hospital. To date, Leiters Health has not received any reports of adverse events related to this recall.

Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events. Administration of vancomycin at twice the infusion rate has been associated with low blood pressure, including shock and cardiac arrest, as well as wheezing, shortness of breath, hives, itchy skin and skin redness. Also, overdosing of vancomycin may be associated with acute kidney injury and ototoxicity. Administration of higher doses of fentanyl than intended can result in profound respiratory depression, which may not automatically be mitigated and treated, resulting in potential for delay in care and serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death. In addition to respiratory depression, fentanyl can cause serious cardiac adverse events, such as hypotension, bradycardia, and vasodilation resulting in decrease in cardiac output and cardiac arrest. In addition, administration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients. To date, Leiters Health has not received any reports of adverse events related to this recall.

Fentanyl is an analgesic packaged in an IV bag under codes F3355 and F3342. Phenylephrine is used for perioperative hypotension, hypotension during anesthesia, and shock and is packaged in an IV bag under codes F3360 and F3352. Vancomycin is used for endocarditis and staphylococcal infections and is packaged in an IV bag under codes F3206 and F3208.

The affected products are:

- Item #F3355, FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag, Lot # Expiration: 2331062 2/8/2024,
2331224 3/18/2024, 2331270 3/28/2024
- Item # F3342, FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag, Lot # Expiration: 233098 1/31/2024, 2331058 2/18/2024, 2331150 3/10/2024, 2331231 3/24/2024, 2331289 3/30/2024.
- Item # F3360, Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2330993 2/15/2024, 2331010 2/10/2024, 2331055 1/18/2024, 2331113 2/26/2024, 2331181 3/4/2024, 2331187 3/23/2024, 2331266 3/31/2024, 2331343 4/1/2024, 2331349 4/23/2024, 2331433 5/5/2024.
- Item # F3352, Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2330939 1/30/2024, 2331032 2/3/2024, 2331112 3/19/2024, 2331190 3/26/2024, 2331429 4/28/2024.
- Item # F3206, Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2331184 2/13/2024, 2331185 2/10/2024, 2331189 2/20/2024, 2331191 2/24/2024, 2331258 3/3/2024, 2331317 3/15/2024.
- Item # F3208, Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL IV Bag, Lot # Expiration: 2331140 2/8/2024, 2331188 2/15/2024, 2331261 3/5/2024, 2331287 3/14/2024

Leiters Health has notified its customers by a letter sent via mail, requiring signature upon receipt, and an email to all affected customers. Leiters Health is arranging for a credit for all recalled products. Customers that have product which is being recalled should cease using it and return it to Leiters Health.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Leiters Health
Brand name: Leiters, Compounding Health
Product recalled: Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
Reason of the recall: Potential for superpotent drug
FDA Recall date: January 08, 2024

Source: fda.gov
See Less
304


WARNING
On December 21, 2023, the FDA published a warning to consumers, healthcare providers, and pharmacists to not use counterfeit Ozempic (semaglutide) injection 1 milligram, which has entered the U.S. drug supply chain. This counterfeit product is labeled with lot number NAR0074 and serial number 430834149057. FDA... See More along with Novo Nordisk (manufacturer of Ozempic) are investigating this issue to determine the identity, quality, and safety of the counterfeit drugs. Additionally, it was found that the needles from these counterfeit samples can't be confirmed to be sterile, which could pose an increased risk of infection for patients. FDA is also aware of 5 non-serious adverse events from this lot, including nausea, vomiting, diarrhea, abdominal pain and constipation, which are common side effects of authentic Ozempic. You can see images of the affected product below.

The FDA advises retail pharmacies to source authentic Ozempic only through authorized distributors of Novo Nordisk to ensure the legitimacy of their shipments. It is recommended that patients only obtain Ozempic with a valid prescription through state-licensed pharmacies, and should check the product for any signs of counterfeiting.

RISKS

The US Food and Drug Administration (FDA) is investigating reports of potential side effects, including hair loss and suicidal thoughts, in individuals using medications containing semaglutide, such as Ozempic, Mounjaro, and Wegovy. Semaglutide, a GLP-1 receptor agonist, mimics the GLP-1 hormone to regulate insulin production, lower blood glucose, and reduce appetite. FDA approved three semaglutide products: Ozempic and Rybelsus for type 2 diabetes, with Ozempic also lowering heart-related risks, and Wegovy aiding weight loss in obesity.

Given the product shortages, there are compounding sales of these medications in the market, however, the FDA has received adverse event reports after patients used compounded semaglutide. This may be due to the use of salt forms of semaglutide. Products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products. Additionally, the FDA has discovered the distribution of illegally marketed semaglutide. These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients.

Semaglutide Medication

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.

In case you experience harm from this medication or the counterfeit product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Sources:
FDA Warning: fda.gov
FDA: fda.gov
FDA: fda.gov
See Less
305


Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® ABBOJECT® Glass... See More Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for the presence of glass particulate matter, identified during product inspection. The products were distributed nationwide to wholesalers/hospitals/institutions in the United States and Puerto Rico from March 14, 2023 through June 29, 2023. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.

The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection and is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.

The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are attached.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of a lot which is being recalled should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Hospira, Inc.
Brand name: Hospira
Product recalled: 4.2% Sodium bicarbonate injection, 8.4% Sodium bicarbonate injection, Atropine sulfate injection
Reason of the recall: Presence of Glass Particulate Matter
FDA Recall date: December 26, 2023

Source: fda.gov
See Less
303


Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and... See More their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray (either before or after this batch code) are in the scope of this recall and may continue to be used by consumers safely and as intended. The affected Americaine® 20% Benzocaine Topical Anesthetic Spray lot was distributed nationwide in the United States through a limited number of retailers and online. To date, the Company has not received any serious adverse events related to this recall.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

Americaine® 20% Benzocaine Topical Anesthetic Spray is packaged in white aerosol cans with Teal caps with Lot codes located on the bottom of the can. Samples of the recalled lot below have been found to contain trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Americaine products.

- Product: Americaine® 20% Benzocaine Topical Anesthetic Spray, NDC: 63736-378-02, Lot Code: 1A16420, Expiration: 01/25, Package Size: 2oz/57g.

Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased Americaine® 20% Benzocaine Topical Anesthetic Spray marked with the lot code in the table above.

Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this anesthetic product.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Insight Pharmaceuticals
Brand name: Americaine
Product recalled: Benzocaine Topical Anesthetic Spray
Reason of the recall: Presence of benzene
FDA Recall date: December 22, 2023

Source: fda.gov
See Less
303


Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial.... See More To date, Pfizer has not received reports of any adverse events related to this recall.

Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience adverse events including injection site reaction, localized vein inflammation or phlebitis, thrombus, embolus and/or end-organ granuloma or life-threatening blood clot events. The risk is reduced by the possibility of detection, as the label contains a statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It should be considered a palliative treatment useful in the management of the neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.

For patients where they, or anyone in close physical contact, do not have a contraindicated device, no action is needed.

- Product: Bleomycin for Injection, USP, 15 Units Single-Dose ONCO-TAIN™ Glass Fliptop Vial, NDC: 61703-332-18, Lot Number: BL12206A, Expiration Date: 30JUN2024, Presentation: 15units/ vial lyophilized, Configuration/Count: 1 vial per carton, 112 vials per case.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution, and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Hospira, Inc.
Brand name: No Brand
Product recalled: Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial
Reason of the recall: Presence of Glass Particulate Matter
FDA Recall date: December 22, 2023

Source: fda.gov
See Less
303


Cipla Limited today announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc. is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level. Vigabatrin for Oral Solution, USP 500 mg has been found to have seal integrity issues allowing for powder leakage from... See More the pouch. The Vigabatrin for Oral Solution, USP 500mg product was distributed nationwide in the USA to partnered distributors and consignees. Cipla has not received any reports of adverse events related to this recall.

An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower content of medicine inside the pouch compared to the label claim and result in potential underdosing.

The product is used for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded adequately to several alternative treatments. Vigabatrin for oral solution is not indicated as a first-line agent. The medication is packaged in foil pouches, each containing 500mg of Vigabatrin, and there are 50 foil sealed pouches in a shelf pack.

The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures requiring immediate emergency room treatment.

The affected Product is as under:
- Vigabatrin for Oral Solution, USP 500mg/sachet. NDC # 6909-7964-53, LOT # NB301030 Expiry Date: 03/2025

InvaGen Pharmaceuticals is notifying the customer level through press releases, letters, telefax, telephone, email, and on-site visits, and is coordinating the return of all recalled products. Distributors, retailers and consumers in possession of Vigabatrin for Oral Solution, USP 500mg Batch No. NB301030, NDC# 6909-7964-53 are advised to initiate the return process through their respective place of purchase.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: InvaGen Pharmaceuticals Inc.
Brand name: No Brand
Product recalled: Vigabatrin for Oral Solution, USP 500mg
Reason of the recall: Due to seal integrity issues allowing for powder leakage from the pouch.
FDA Recall date: December 11, 2023

Source: fda.gov
See Less
303


Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. The products have been found to be tainted with Sildenafil. Products containing sildenafil cannot be marketed as dietary supplements. Magnum XXL 9800 capsules is an unapproved new... See More drug for which safety and efficacy have not been established and, therefore, subject to recall. The product was distributed and sold online on Amazon under the ASINs: B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ. To date, Meta Herbal has not received any reports of adverse events related to this recall.

Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction.

Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister packs of one pill, with a UPC 645759993007 exp 1/2025. Each blister pack is sold individually and holds one capsule.

Meta Herbal is notifying its customers via Amazon and is arranging for refunds. All blister packs of Magnum XXL 9800 are affected by this recall. Consumers who have the recalled product should stop using it and contact Meta Herbal for return/refund instructions.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Meta Herbal
Brand name: Magnum
Product recalled: Magnum Male Sexual Enhancement XXL 9800 capsule
Reason of the recall: Undeclared Sildenafil
FDA Recall date: November 29, 2023

Source: fda.gov
See Less
303


Last 30 days