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Drugs

Updated: December 7, 2021 3:03 PM
FOR IMMEDIATE RELEASE – December 4, 2021 – Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility... See More assurance for products intended to be sterile and could impact the safety and quality of non-sterile products.

Risk Statement: Administration of a drug product intended to be sterile, that is not sterile, could result in site specific infections as well as serious systemic infections which may be life- threatening. To date, Edge Pharma, LLC has not received and is not aware of any adverse events related to this recall. The products are used for a variety of indications and are packaged in Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars. The affected lots and expiration dates are included in the link listed below. The names and concentration of the drugs are listed in the link below.

The recall encompasses all compounded sterile and nonsterile drug products, within expiry, that were dispensed from Edge Pharma, LLC. The products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The products can be identified by the label containing the Edge Pharma, LLC name and logo. Edge Pharma, LLC is notifying its customers by email, Media and FDA alerts, and direct outreach.

Consumers and institutions that have Edge Pharma, LLC products should stop using the products immediately and may either return or discard the recalled lots. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Edge Pharma, LLC
Brand name: Edge Pharma, LLC
Product recalled: All drugs compounded at Edge Pharma, LLC
Process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products
FDA Recall date: December 07, 2021

Check the full recall details on fda.gov

Source: FDA
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FOR IMMEDIATE RELEASE –07 December 2021 – Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml in a screw cap glass bottle listed below to the user level. The product is being recalled because the firms testing has... See More found it to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) 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: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle
NDC: 63739-997-64
Lot Number: 15594
Expiration: 05/2023

Product: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle
NDC: 63739-997-64
Lot Number: 16345
Expiration: 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 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 nationwide in the US.

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Teligent Pharma, Inc.
Brand name: Teligent Pharma, Inc.
Product recalled: Lidocaine HCl Topical Solution USP 4%, 50ml
Reason of the recall: Super potent
FDA Recall date: December 07, 2021

Check the full recall details on fda.gov

Source: FDA
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Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD) today announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level. Gilead Sciences Inc. received a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates.

Risk Statement:... See More The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead Sciences Inc. has not received any reports of adverse events related to this recall.

Veklury is indicated for the treatment of adults and pediatric patients ≥ 12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. The lyophilized form of Veklury (remdesivir 100 mg for injection) is distributed in single dose clear glass vials in powder form and reconstituted at the site of use.

Veklury lots 2141001-1A and 2141002-1A were distributed nationwide in the United States, beginning October 2021. NDC, lot, expiration date and distribution dates can be found below.

Product Description: Veklury® (remdesivir 100mg for injection)
NDC: 61958-2901-02
Lot #: 2141001-1A - 2141002-1A
Expiration Date: 01/2024 - 01/2024
Distribution date to wholesalers: 10/25/21-10/26/2021 - 10/26/21-11/02/2021

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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FOR IMMEDIATE RELEASE – 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... See More 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: Enoxaparin Sodium, Injection, USP 40mg/0.4 mL
NDC Number: 00781-3246-64
Lot Number: SAB06761A
Expiration Date: 04/2023
Date of Manufacture: 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.

Company name: Sandoz, Inc.
Brand name: Sandoz
Product recalled: Enoxaparin Sodium Injection
Reason of the recall: Exposure to high temperatures may have impacted product effectiveness.
FDA Recall date: December 02, 2021

Check the full recall details on fda.gov

Source: FDA
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Sagent Pharmaceuticals, Inc. on November 19 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... See More 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: Levetiracetam Injection, USP / Lot Number: B0G85VB /Expiration Date: Jun-2022 / NDC Number: 25021-780-05 / Distribution Dates: May 2021 - August 2021.

Product: Levetiracetam Injection, USP / Lot Number: B0K88VA /Expiration Date: Sep-2022 / NDC Number: 25021-780-05 / Distribution Dates: March 2021 - November 2021.

Product: Levetiracetam Injection, USP / Lot Number: B0K89VA /Expiration Date: Sep-2022 / NDC Number: 25021-780-05 / Distribution Dates: August 2021 - November 2021.

Product: Levetiracetam Injection, USP / Lot Number: B1G194A /Expiration Date: Jun-2023 / NDC Number: 25021-780-05 / Distribution Dates: October 2021.

The product was distributed Nationwide from March to November  2021.

Company name: Sagent Pharmaceuticals, Inc.
Brand name: Sagent
Product recalled: Levetiracetam Injection
Reason of the recall: Lack of sterility assurance
FDA Recall date: November 22, 2021

Check the full recall details on fda.gov

Source: FDA
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KENILWORTH, N.J., Oct. 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... See More 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. CUBICIN is a lipopeptide antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age), and Staphylococcus aureus bloodstream infections (bacteremia) in adult patients including those with right-sided infective endocarditis, and Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age).

CUBICIN is packaged in single-dose, 10 mL glass vial containing 500 mg of daptomycin as a sterile, lyophilized cake, NDC 67919-011-01. There were 76,163 total vials manufactured in the affected lot; and of those vials, 21,603 have been distributed. The affected CUBICIN lot includes the following: Bulk drug product and packaged lot 934778, expiration date June 2022. This product was distributed to wholesalers between June 1, 2021, and Sept. 9, 2021, in the U.S.

Merck is notifying its distributors and customers and is arranging for return of all recalled product by sending recall notices via UPS Next Day Air to all nine Merck direct consignees with a physical address.

Company name: Merck
Brand name: CUBICIN
Product recalled: Daptomycin for injection 500mg
Reason of the recall: Product contains particulate matter identified as glass
FDA Recall date: October 20, 2021

Check the full recall details on fda.gov

Source: FDA
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Company name: Bryant Ranch Prepack
Brand name: Bryant Ranch Prepack
Product recalled: Methocarbamol 500mg
Reason of the recall: Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets.
FDA Recall date: October 19, 2021
Recall details: Burbank, CA, Bryant Ranch Prepack is voluntarily recalling... See More 1 lot of Methocarbamol 500mg, Tablets to the consumer level. The bottles labeled as Methocarbamol 500mg Tablets have been found to contain Methocarbamol 750mg Tablets.

Risk Statement: If a patient takes a 750mg Tablet of Methocarbamol instead of the prescribed 500mg Tablets, it potentially could result in Excessive Central Nervous System depression which may result in nausea, sedation, fainting, falls, seizure, coma, and death. Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

The product is used together with rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions and is packaged in a white round bottle with a red and white label, which reads Methocarbamol 500mg packaged in counts of 30 (NDC:7133517952), 60 (NDC: 7133517954), and 90 (NDC:7133517957) pills. The affected Methocarbamol 500mg lots include the following Lot Number 163935/ Exp. Date 10/22. The product can be identified by red and white label with a yellow border at the top and bottom of the label, top of the label reads “Packaged by Bryant Ranch Prepack”, labels are pictured below. The Methocarbamol 500mg was distributed Nationwide to multiple physician offices.

Bryant Ranch Prepack is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Consumers that have the bottles labeled as Methocarbamol 500mg Tablets which is being recalled should stop using immediately and return to place of purchase and/or contact their physician. Distributors/Physicians should stop distribution and contact Bryant Ranch Prepack to return the product immediately.

Check the full recall details on fda.gov

Source: FDA
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Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg
Reason of the recall: API batches above the specification limit for the impurity, N-nitrosoirbesartan
FDA Recall date: October 14, 2021
Recall details: Baltimore, Maryland, October 14, 2021:... See More 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. The recalled lots are included in the link below.

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. The recalled lots are included in the link below.

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking, Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg that are being recalled should discontinue distribution of the recalled product lots immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 769-3988 / (855) 769-3989.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.

Check the full recall details on fda.gov

Source: FDA
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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... See More 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.

- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle. NDC: 52565-009-50. Lot number/Expiration: 13262 / 03/2022 | 14217 / 08/2022 | 13058 / 02/2022 | 13768 / 05/2022. NDC: 63739-997-64. Lot number/Expiration: 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.

Consumers and patients that have Lidocaine HCl Topical Solution 4% which is being recalled are asked to discontinue use and dispose of the product immediately.

Company name: Teligent Pharma, Inc.
Brand name: Teligent Pharma, Inc.
Product recalled: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL)
Reason of the recall: Super Potent
FDA Recall date: October 12, 2021

Check the full recall details on fda.gov

Source: FDA
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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. To date, Bayer... See More has no known reports of adverse events related to this recall.

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.

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 that 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.

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 the link below. 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.

Bayer is also notifying its distributors and retailers by letter and is arranging for returns of all voluntarily recalled products. Consumers who have the products that are being recalled should stop using them.

Check the full recall details on fda.gov

Company name: Bayer U.S. LLC
Brand name: Lotrimin® AF and Tinactin®
Product recalled: Over the Counter (OTC) antifungal spray products
Reason of the recall: Presence of benzene
FDA Recall date: October 01, 2021

Source: FDA
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