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Recall

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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Livia Global, Inc announced the recall of two lots of its liquid probiotics, LiviaOne Liquid Probiotics & BioLifePet Liquid Probiotics, due to the possibility of contamination by Pseudomonas aeruginosa, a microorganism that can cause life-threatening infection in immunocompromised individuals. These products are distributed nationwide through Amazon, wholesale,... See More and direct sales from the company’s website.

Pseudomonas aeruginosa is a microorganism found in the environment that, if ingested, can cause life-threatening infection in immunocompromised individuals. P. aeruginosa infections are generally limited to hospital settings.

This recall only affects the following products with the Lot# 001005-1 Best by: 04/2023 & LiviaOne Nasal Probiotics with Lot# 010620-1 Best by 08/2023 with the following ship dates:
- LiviaOne Daily Probiotics 2oz – UPC 030915 107112 Ship dates 04/16/2021 – 08/30/2021 (1067 units)
- LiviaOne Daily Probiotics 4oz – UPC 030915 107167 Ship dates - 07/09/2021 – 08/30/2021 (384 units)
- LiviaOne Topical Spray Probiotics 4oz – UPC 030915 107105 Ship dates 07/08/2021 – 07/30/2021 (571 units)
- LiviaOne Nasal Probiotics 1oz – UPC 030915 107198 Ship dates 04/21/2021 – 05/12/2021 (480 units)
- LiviaOne Nasal Probiotics 1 oz - UPC 030915 107198 Ship dates 07/14/2021 – 08/24/2021 (600 units)
- LiviaOne Nasal Probiotics 1 oz – Lot# 010620-1 UPC 030915 107198 Ship dates 10/27/2021 – 11/25/2021 (50 units)
- BioLifePet Probiotics for Cats – UPC 030915 107044 Ship dates 05/05/2021 – 07/26/2021 (128 units)
- BioLifePet Probiotics for Dogs – UPC 030915 107037 Ship dates 05/05/2021 – 08/25/2021 (128 units)

Lot numbers are located on the side of the bottle and on the bottom of the outer container in which the product is sold. No other lots or ship dates or any other LiviaOne products are affected by this recall.

Company name: Liva Global, Inc.
Brand name: LivaOne and BioLifePet
Product recalled: Probiotics
Reason of the recall: Pseudomonas aeruginosa
FDA Recall date: December 01, 2021

Check the full recall details on fda.gov

Source: FDA
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Nutrisure Ltd is recalling Naturya Hemp Protein Powder because it contains gluten, which is not mentioned on the label. This means the product is a possible health risk for anyone with an allergy or intolerance to gluten. This batch was only sold in Sainsbury’s stores.

Naturya Hemp... See More Protein Powder (100g)
Pack size: 100g
Batch code: W02135
Best before: end of March 2024
Allergens: Gluten

If you have bought the above product and have an allergy or intolerance to gluten, do not eat it. Instead, return it to the store from where it was bought for a full refund.

Company name: Nutrisure Ltd
Product recalled: Naturya Hemp Protein Powder
FSA Recall date: 11/30/2021

Check the full recall details on food.gov.uk

Source: FSA
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International Golden Foods, Inc (IGF) of Bensenville, IL is voluntarily recalling certain lot codes of the Al kanater brand tahini because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people... See More and others with weakened immune system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The product was distributed nationwide and is sold in 16 Oz. jars. The jars are labelled “Al kanater Tahini.” Lot codes are printed on the jar. Product code, description, lot code, and UPC information are noted below.

Product Code: AT1LB
Product Description & Size: Al kanater Tahini Sesame Paste 1 lb. (454 gr)
Lot #: TT4N‐201127
UPC: 6‐92551‐00002‐0

No illnesses have been reported to-date in connection with the Al Kanater Brand Tahini.

This problem was revealed as a result of a random sampling by the Michigan Department of Agriculture.

Consumers who have purchased Al kanater Tahini with these lot codes should discontinue use and return it to the store of purchase for a full refund. Retailers that may have further distributed the recalled lot codes should share this notice with their customers.

Company name: International Golden Foods, Inc.
Brand name: Al Kanater
Product recalled: Tahini
Reason of the recall: Salmonella
FDA Recall date: November 30, 2021

Check the full recall details on fda.gov

Source: FDA
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Odor-Eaters®, owned by Blistex Inc., is voluntarily recalling a total of forty-one lots of two Odor-Eaters® spray products to the consumer level due to the presence of benzene. Internal testing identified low levels of benzene contamination in specific lots of these aerosol products.

Risk Statement: Benzene is... See More classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening.

To date, Odor-Eaters® has not received any reports of adverse events related to this recall. The affected Odor-Eaters® spray products are used as antifungal and foot odor-reducing agents and are packaged in aerosol cans. See the link below for UPC, lot number and expiration dates. Refer to the image below for guidance on where to find the lot code details on the can. Forty-one lots of two Odor-Eaters® spray products (Odor-Eaters® Spray Powder and Odor-Eaters® Stink Stoppers® Spray) are impacted by this voluntary recall, specifically the ones listed in the link below.

The products were distributed nationwide in the United States through various retailers. Consumers, distributors, and retailers that have product which is being recalled should stop using or selling these specific Odor-Eaters® spray products and dispose of them appropriately.

Company name: Odor-Eaters®, owned by Blistex Inc.
Brand name: Odor-Eaters®
Product recalled: Oder Eaters spray products
Reason of the recall: Due to the presence of benzene
FDA Recall date: November 17, 2021

Check the full recall details on fda.gov

Source: FDA
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American Screening LLC of Shreveport, Louisiana is voluntarily recalling 153,336 units of Hand Sanitizer, containing 70% ethyl alcohol gel to the consumer level. The hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption.

Risk Statement: Ingesting hand sanitizer, which... See More is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. To date, American Screening LLC has not received any reports of adverse events related to this recall.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in an eight-ounce bottle. The affected hand sanitizer lots include the following expiration dates of 5/21/2022 and 05/24/2022 for black-capped bottles and no lot numbers or expiration dates for clear capped bottles. The product can be identified by its shape (small water bottle), with a black flip top cap or clear cap with blue pouring spout with the weight of measure of eight (8) ounces/237mL, UPC 8 4005051579 2.

The Hand Sanitizer was sold to customers & distributors Nationwide via the internet at americanscreeningcorp.com and/or in-house sales.

Consumers & distributors that have this hand sanitizer which is being recalled should stop distribution/use and return to place of purchase or discard. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to ingesting the hand sanitizer packaged in the 8 oz. water bottle style.

Company name: American Screening LLC
Brand name: American Screening
Product recalled: Hand Sanitizer
Reason of the recall: Hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption
FDA Recall date: November 19, 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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