Drugs

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

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: www.fda.gov

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: www.fda.gov

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: www.fda.gov

during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted. They were distributed nationwide to wholesalers across the US, beginning in January 2022 and September 2022, respectively. Novartis has not received any reports of adverse events related to this recall, to date.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Risk Statement: Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if overexposure continues.

The affected lot numbers and expiration dates are:
- FX001500 (expiration date 09/2024)
- FX001582 (expiration date 09/2024) NDC 0078-0110-22.
These lots were only distributed in the US.

Novartis is notifying its distributors via a recall notification letter and is arranging for the return of the recalled lot from distributors, retailers, and consumers. Additionally, Novartis is notifying healthcare providers who have prescribed this product to contact their patients. Consumers who have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their healthcare provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare provider.

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: Novartis Pharmaceuticals Corporation
Brand name: Novartis
Product recalled: Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL
Reason for the recall: Due to crystallization formation
FDA Recall date: November 27, 2023

Source: www.fda.gov

product contained elevated levels of benzene. The affected lots were 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 exposure to it indoors and outdoors from multiple sources.

TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder is packaged in green 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 trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.
Affected products:
- Product: TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder, NDC: 63736-532-05, Lot Code: 0H88645, Expiration: 07/24, Package Size: 4.5 oz/128 g
- Product: TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder, NDC: 63736-532-05, Lot Code: 0B88345, Expiration: 02/24, 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® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray marked with one of the lot codes.

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: 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal SprayPowder
Reason for the recall: Presence of benzene
FDA Recall date: November 24, 2023

Source: www.fda.gov

specialty pharmacies nationwide between January 3, 2023, and February 13, 2023. To date, Bayer has not received any adverse events related to this recall.

Risk Statement: Vitrakvi® is indicated for the treatment of solid tumors that are NTRK gene fusion positive, it is expected that patients on Vitrakvi® may be immunocompromised. Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi® with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening.

The impacted lot of Vitrakvi® is packaged in a 100mL glass bottle with NDC# 50419-392-01 and is identified with Lot# 2114228 and an expiration date of February 29, 2024. Product bottle and carton label images and information on the lot number that falls under this recall is attached

Bayer notified all distributors and pharmacies of this recall on November 8, 2023. Bayer has engaged Qualanex to manage the recall of the product down to the consumer level. Qualanex has notified Vitrakvi® distributors via a recall notification letter and will arrange for the return of the recalled lot from distributors, specialty pharmacies, and consumers.

Consumers who have the recalled Vitrakvi® product should immediately stop use of this particular lot of product and contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to Vitrakvi® Oral Solution 20 mg/mL.

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: Bayer
Brand name: Bayer
Product recalled: Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles
Reason of the recall: Microbial contamination identified as Penicillium brevicompactum
FDA Recall date: November 21, 2023

Source: www.fda.gov

Wholesale has not received any reports of adverse events related to this recall to date.

Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in this product renders the rock an unapproved drug for which the safety and efficacy have not been established and, therefore, subject to recall.

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 Rock is marketed as a dietary supplement for male sexual enhancement and is packaged as a single pill in a blister pack. It is labeled as ORIGINAL THE ROCK, Male sexual performance, with the following UPC 6 61799 95052 7. Distributed by: Steele Products, Hallandale, FL. The Rock affected lot is lot#03032021, Exp:12/2027. The product can be identified by the red and black lettering on a white-flat small cardboard package with one red capsule seen through a clear blister window.

Noah’s Wholesale is notifying its distributors and customers by phone, emails, and through their sales representative and is arranging for a full refund/credit of all recalled products. Consumers who have the recalled product should stop using the product and return it to the place of purchase or discard the product immediately. Distributors and retailers should stop selling the product and contact Noah’s Wholesale LLC for a refund process.

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: Noah’s Wholesale, LLC
Brand name: Noah’s Wholesale, LLC
Product recalled: Dietary Supplement with undeclared Sildenafil
Reason of the recall: Undeclared drug, Sildenafil
FDA Recall date: November 21, 2023

Source: www.fda.gov

direct delivery and national retailers, and online through major ecommerce sites. The company has not received any reports of serious adverse events from either of these products to date.

The two products were manufactured and packaged for KinderFarms by a major, U.S.-based OTC pharmaceutical manufacturer with over 30 years of experience. Ongoing testing of sample batches indicated some product lots were no longer in specification and may pose a health risk. Acetaminophen is the active ingredient in many pain-relieving medicines. As a result of the potential health risk with acetaminophen being outside of specification, the product may cause acute adverse health effects, including abdominal pain, nausea, vomiting or jaundice at higher doses.

This voluntary recall encompasses all products currently available on shelf of these two SKUs only. The impacted product being voluntarily recalled is all lots of:
- KinderMed Infants’ Pain & Fever (2 fluid ounces/59 mL), (Acetaminophen - 160 mg per 5 mL), Oral Suspension. UPC: 850001805698
- KinderMed Kids’ Pain & Fever (4 fluid ounces/118 mL), (Acetaminophen - 160 mg per 5 mL), Oral Suspension. UPC: 850001805728

Consumers who purchased either of these two products should stop using them and may return the product to the place of purchase for a full refund.

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: KinderFarms, LLC
Brand name: KinderMed
Product recalled: OTC Pain and Fever Reliever for Infants and Kids
Reason of the recall: Due to Acetaminophen Instability
FDA Recall date: November 17, 2023

Source: www.fda.gov