Drug Recalls

Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping -

 

December 1, 2021 – Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021.

The exposure to higher temperatures may have significantly impacted the recalled product’s (lot SAB06761A) effectiveness and thus there may be reasonable probability of risk for patients with health conditions that the product is intended to treat. Such patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots to the lung or death as a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries related to this recall.

The product is used for prevention of deep vein thrombosis (DVT) a condition that occurs when a blood clot forms in a deep vein, usually in the legs that can occur after surgeries or in patients with restricted mobility during illness; or prevention of complications associated with heart attacks. The product is packaged in cartons containing ten 0.4 mL syringes, NDC 0781-3246-64. Enoxaparin Sodium Injection was distributed Nationwide in the USA to wholesalers and retailers.



Product Name

NDC Number

Lot
Number

Expiration
Date

Date of
Manufacture

Enoxaparin Sodium
Injection, USP

40 mg/0.4 mL

00781-3246-64

SAB06761A

04/2023

05/26/2021



Please note: this recall is specific to only one batch (SAB06761A) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL SKU.

Any product returned that is not associated with this recall will be destroyed and no credit issued.



Sandoz has already notified its wholesalers and retailers by mail and is arranging for return of all recalled product.

Consumers who have Enoxaparin Sodium Injection, USP 40 mg/0.4 mL (NDC 00781-3246-64 and Lot number SAB06761A) which is being recalled, should stop taking the recalled product, immediately consult with their physician to attain another prescription, and return the product where originally purchased. 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.​

 

 



For more information about this recall, please visit the FDA website



Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance -

CHICAGO, IL – November 19, 2021 - Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product.

Risk Statement: Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening.  To date, Sagent has not received reports of any product complaints or adverse events associated with this issue.

Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial. The Levetiracetam Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below.  Product was distributed Nationwide from March to November 2021.

 

 

Product

Lot
Number

    Expiration Date

    NDC     Number

    Distribution Dates

Levetiracetam Injection, USP B0G85VB     Jun-2022     25021-
    780-05
May 2021 -
August 2021
B0K88VA    Sep-2022 March 2021 -
November 2021
B0K89VA    Sep-2022 August 2021 -
November 2021
B1G194A    Jun-2023 October 2021 

 

 

Sagent Pharmaceuticals, Inc.  is notifying customers by fax, email, FedEx, and/or certified mail, which includes arrangements for return of all recalled product. Customers that have Levetiracetam Injection, USP 500mg per 5 mL, which is being recalled, have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Healthcare/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form to document product information, as well as other information regarding this recall, is available at www.Sagentpharma.comExternal Link Disclaimer.

Consumers or healthcare workers with any questions regarding this recall can contact the customer call center (866) 625-1618 M-F, 8am-7pm CST. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

 



For more information about this recall, please visit the FDA website



On October 27, 2021 -

On August 19, 2021, Aligned Medical Solutions initiated a nationwide recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into 9,378 kits. Including;
 

  • 1 lot of AMS-9041CP Leaderflex Insertion Kit with Ultrasound
  • 1 lot of AMS-9046CP-1 Insertion Tray-RX
  • 45 lots of AMS8939A Universal Procedure Pack w/Split Drape
  • 1 lot of AMS9957A Port Insertion Pack
  • 3 lots of AMS12149 Procedure Pack

These convenience kits have been found to contain the Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe part # 8881570121, which has been recalled for the potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe. If a clinician is not aware of air being introduced into the syringe, the clinician could inadvertently push air into the vascular system creating the potential for an air embolism. Injection of air into the vascular system can cause air embolism which can result in serious adverse health consequences or death.

See Cardinal Health’s Urgent Medical Device Recall Event 2021-04063 Monoject™ Flush Prefilled Saline Syringes https://www.cardinalhealth.com/en/cmp/ext/corp/monoject-flush-prefilled-saline-syringes-issue.htmlExternal Link Disclaimer

Consumers who have affected product(s) should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement product if needed at 407-638-9924. Customers will be provided with a yellow label that is to be placed on the packs containing the recalled Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe. The label will read as follows;
 

  1. At the time the kit is opened for use the prefilled syringe manufactured by Cardinal Health should be identified, set aside and not used. Do not use the prefilled syringe in the kit.
  2. The recalled prefilled syringe should be rendered unusable to protect against inadvertent use and disposed or pursuant to the medical waste policies in effect at your institution

Consumers can request replacement syringes by calling 407-638-9924.

Recalled Product(s) were manufactured from 01/13/2020 to 10/14/2020 and distributed from 01/23/2020 to 10/19/2020.

 

 



For more information about this recall, please visit the FDA website



On October 19, 2021 -

Merck (NYSE: MRK), known as MSD outside the United States and Canada, is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions. Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution. 



Intravenous infusion of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient. Local irritation or swelling at the infusion site may occur in response to the presence of foreign material. More serious potential outcomes include blockage and clotting in blood vessels, which can be life-threatening if a critical organ is affected. Other clinical consequences could include prolonged hospitalization, particularly in those patients receiving an extended treatment regimen for which multiple vials of CUBICIN are administered over the course of treatment. 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 prior to administration. To date, Merck has not received any reports of adverse events related to this recall.



For more information about this recall, please visit the FDA website



On October 14, 2021 -

Baltimore, Maryland, October 14, 2021: Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.

Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021.

Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide.

Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021.​​

Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Irbesartan and hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021



For more information about this recall, please visit the FDA website



Lidocaine HC1 Topical Solution -

Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.

Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall.

 

Product NDC Lot Number Expiration
Lidocaine Hydrochloride Topical Solution USP 4$ (40 mg/mL), 50 mL bottle 52565-009-50 13262 03/2022
    14217 08/2022
    13058 02/2022
    13768 05/2022
  63739-997-64 16306 01/2024

 


The product is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract and is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50 and 63739-997-64. The product can be identified by the following labeling: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). Product was distributed at the wholesale and retail distribution levels in the US and Canada.

Teligent Pharma, Inc. is notifying its distributors via Fed-Ex and is arranging for return of all recalled products.​
 

 

 

 



For more information about this recall, please visit the FDA website



On October 5, 2021 -

Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product
 

  • All MiniMed Remote Controllers (model MMT-500 and MMT-503) used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps
  • Distribution Dates: August 1999 to July 2018
  • Devices Recalled in the U.S.: 31,310
  • Date Initiated by Firm: August 7, 2018

Device Use

People who have diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The pump system includes an optional remote controller device which is designed to communicate wirelessly with the pump to deliver a specific amount of insulin to the person with diabetes.

The following table shows the recalled Medtronic remote controllers, used with the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps. The remote controllers impacted by this issue are older models that use previous-generation technology. As of July 2018, Medtronic is no longer manufacturing or distributing these remote controllers.

Reason for Recall

Medtronic is recalling all remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump. Using specialized equipment, an unauthorized person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death.

If you have never programmed a remote controller ID into the pump and never programmed the easy bolus option, you are not impacted by this vulnerability.

To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.

Who May Be Affected
 

  • Any person who uses the remote controller feature with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps
  • Health care providers and caregivers who treat people with diabetes who use remote controllers associated with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps

What to Do

On October 5, 2021, Medtronic began notifying anyone who may still be using the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps and have purchased a remote controller of the expanded recall. Medtronic provided the following instructions:

If you use a recalled remote controller:

  • Stop using the remote controller.
  • Turn off the easy bolus feature.
  • Disconnect the remote controller from your insulin pump:
  • First, you must turn off the radio frequency function and delete all remote controller IDs that are programmed into your insulin pump.
  • Then, follow the instructions in the appendix attached to Medtronic’s letter. The steps to disconnect the remote controller will vary by insulin pump model.

 

 



For more information about this recall, please visit the FDA website



On October 5, 2021 -

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing  

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • MiniMed™ 600 Series Insulin Pumps
  • Lot codes: Refer to the Medical Device Recalls database entry for each product.
  • Distribution Dates:
    • Model 630G - September 2016 to February 2020
    • Model 670G - May 2015 to December 2020
  • Devices Recalled in the U.S.: 463,464
  • Date Initiated by Firm: November 21, 2019

Device Use

People who have Type 1 diabetes may use the MiniMed™ insulin pump to deliver insulin for the management of their diabetes.

  • The Model 630G insulin pump may be used by persons sixteen years of age and older.
  • The Model 670G insulin pump may be used by persons seven years of age and older.

Reason for Recall

Medtronic is recalling the specified insulin pumps to replace any pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.

Medtronic previously identified, and informed customers about missing or broken clear retainer ring of the MiniMed™ 630G and 670G insulin pumps. The retainer ring helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). Severe hyperglycemia and hypoglycemia can be life-threatening or may result in death.

  • Example of hypoglycemia risk - If the retainer ring is broken or becomes detached from the insulin pump, and the user inserts the reservoir back into the pump while the infusion set is still connected to the body, it could result in a rapid and potentially large infusion of insulin.
  • Example of hyperglycemia risk - The under delivery of insulin could occur if the reservoir is not properly locked in place by the retainer ring, creating a space between the insulin pump and the reservoir, and prevents the pump from pushing the expected insulin into the body, or if the pump stops working due to water entering the insulin pump. This may also contribute to diabetic ketoacidosis.

Serious injuries and deaths have been reported with the use of MiniMed™ 600 series insulin pumps, however those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall. ​
 

 



For more information about this recall, please visit the FDA website



On October 1, 2021 -

Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow and blood disorders which can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally. To date, Bayer has no known reports of adverse events related to this recall.

The affected Lotrimin® and Tinactin® spray products are over the counter antifungal products, sold individually or in combo packs. The impacted products are:
 

  • Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
  • Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
  • Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
  • Lotrimin® AF Athlete's Foot Liquid Spray
  • Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
  • Tinactin® Jock Itch (JI) Powder Spray
  • Tinactin® Athlete’s Foot Deodorant Powder Spray
  • Tinactin® Athlete’s Foot Powder Spray
  • Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at: https://livewell.bayer.com/document/2011External Link Disclaimer.External Link Disclaimer

There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada and Mexico through a variety of retail channels.​
 



For more information about this recall, please visit the FDA website



On September 25, 2021 -

Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.



Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.



For more information about this recall, please visit the FDA website



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Drug Recall Process

The U.S. Food and Drug Administration (FDA) has jurisdiction over food, drugs, cosmetics, medical devices and other products and services as a monitor over product recalls. In most cases recalls are done voluntarily by the manufacturer or the distributor of the product. In some cases, a company will discover that one of its products is defective and will recall it. In other cases, the FDA will notify a company that one of its products is defective and will suggest or request a recall.

The FDA has guidelines for companies to follow in recalling defective products. These guidelines explain that the FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. The guidelines categorize all recalls into one of the three classes according to the level of hazard involved.

  • Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
  • Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
  • Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violates FDA regulations.


Navitus Health Solutions LLC is a transparent Pharmacy Benefit Manager for a variety of health care plans. Navitus is not owned or operated by an entity related to the pharmaceutical manufacturing industry. Navitus is also not responsible for the manufacture, distribution or recall of any medication. This notification is meant solely to provide information to our clients, members and policyholders, regarding the various recalls of medications by the FDA. Navitus assumes no liability for the information contained in these notifications.

 

This plan, Navitus MedicareRx (PDP), is offered by Navitus Health Solutions and underwritten by Dean Health Insurance, Inc., A Federally-Qualified Medicare Contracting Prescription Drug Plan.