Drugs

a limited number of retailers and online. No serious adverse events have been reported to date.

TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid is packaged in blue and white aerosol cans with Lot codes located on the bottom of the can. Samples of the recalled lots below have been found to contain elevated levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.

- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 0H50545, Expiration Date: 07/24, Package Size: 4.5 oz/128 g.
- Product: TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid, NDC: 63736-819-05, Lot Number: 1G50645, Expiration Date: 06/25, Package Size: 4.5 oz/128 g.
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 TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid marked with one of the lot codes in the table above.

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. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

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: TING®
Product recalled: 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid
Reason of the recall: Presence of benzene
FDA Recall date: February 02, 2024

Source: www.fda.gov

reported any adverse events from the use of its products.

The FDA has advised that: There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks including confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use. Further, the risks of adverse effects associated with use of tianeptine along with antidepressants, known as monoamine oxidase inhibitors (MAOls), are potentially serious and life-threatening.

Neptune's Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles with a "shrink sleeve" label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune's Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. All Neptune's Fix products are being recalled. The product can be identified by the name Neptune's Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident.

Neptune Resources is notifying its distributors and customers by form of a mailed out recall letter and is arranging for the return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using it and return it to place of purchase immediately.

In case you experience harm from allergens or undeclared ingredients, 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: Neptune Resources, LLC
Brand name: Neptune’s Fix
Product recalled: Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets
Reason of the recall: Undeclared Tianeptine
FDA Recall date: January 29, 2024

Source: www.fda.gov

tablets of Carbinoxamine Maleate, an antihistamine drug. The product was distributed nationwide through pharmacies. To date, Azurity has not received any reports of serious adverse events related to this recall.

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery).

Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand. Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc.

Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side. Following are the details of the recalled product:

- Product: Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg, NDC No.: 24338-856-03, Lot No.: F230169A, Exp. Date: 2025-06, Ship Dates to Wholesalers: 08/23/2023 – 11/29/2023.

Azurity Pharmaceuticals, Inc. sent recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level. Consumers who have a product that is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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: Azurity Pharmaceuticals, Inc.
Brand name: Zendedi
Product recalled: dextroamphetamine sulfate tablets, 30 mg
Reason of the recall: Mislabeled package
FDA Recall date: January 25, 2024

Source: www.fda.gov

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: www.fda.gov

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: www.fda.gov

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

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: www.fda.gov

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: www.fda.gov
FDA: www.fda.gov
FDA: www.fda.gov

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: www.fda.gov

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: www.fda.gov