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Lupin Irbesartan and Hydrochlorothiazide Tablets - recalled due to of N-nitrosoirbesartan impurity, USA

1 month ago

United States

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: 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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Related Reports

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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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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2 Shares


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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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 –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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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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Boil Water Order is still in effect. Saranac Lake Water Main Break for Duprey St. to Edwards St. (including all of Lakeview Terr. and Tara Dr.). Please be advised that a water main break has caused the NY Health Dept. to issue a Boil Water Order.

Source:... See More twitter.com
Source publication date: 2021 12 08
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A boil water advisory has been issued for a portion of the City of Kingman and for Kingman County Rural Water District No. 1, Kingman County.

Source: twitter.com
Source publication date: 2021 12 08 See Less


Over 15,000 without power on south Whidbey Island; some schools canceled.

Source: kiro7.com
Source publication date: 2021 12 08 See Less


Over 15,000 without power on south Whidbey Island; some schools canceled.

Source: kiro7.com
Source publication date: 2021 12 08 See Less


Recent Interesting Reports

Nutracap Holdings, LLC of Norcross, Georgia is voluntarily recalling various dietary supplements due to undeclared milk on the labels. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume products containing milk. There have been... See More no illnesses reported to date.

During a recent FDA inspection, the firm was notified that their labels failed to disclose the presence of milk on some of their products.

The recalled products were shipped between January 2020 through November 2021 to distributors and retailers in Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Nevada, New Jersey, New York, North Carolina, Ohio, and Texas.

The full list of affected products is on the link below.

Lot numbers and expiration dates are found on the bottom of each container.

Retailers and distributors who have received any of these products should check inventory, immediately remove from sale and notify customers who purchased them of the recall. Nutracap will be providing corrective label stickers for product remaining in stock. Affected consumers who have purchased these products are urged to return them to the place of purchase for a full refund or they may discard the product. Your assistance is appreciated and necessary to prevent consumer illness.

Company Announcement Date: November 12, 2021
FDA Publish Date: November 12, 2021
Product Type: Food & Beverages. Allergens
Reason for Announcement: Undeclared Milk
Company Name: Nutracap Holdings, LLC
Brand Name: Multiple brands
Product Description: Dietary Supplements

Check the full recall details on the FDA website: fda.gov

Source: FDA
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101


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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101


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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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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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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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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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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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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Usually is fine. Not this time. I decided to burn Nag Champa incense to meditate. As I was meditating, our dog started sniffling and then began throwing up large amounts of mucous. Her lips were swollen and pulled back slightly. She is ok now, but I've never... See More experienced anything like this using incense before this happened. I often use it for meditation. I called the vet who confirmed this is an allergic reaction and they informed me to monitor her and ensure she is safeand healthy, not vomiting anymore. They instructed me to open all the windows and doors, turn on ceiling fans,and run the furnace heat to pull remaining particulate into the HEPA filter on the furnace and then to replace the filter tomorrow to ensure it doesn't just recirculate the particulate if any happens to get through. Also said to wash hard surfaces in the room it was burned on and vacuum up any furniture,carpet, or rugs there to remove any settled particulate. I'm not sure what went wrong here. I've never had this happen with her or any other dog when burning this.

But even I am sniffling and nauseous after having burned it and my throat is sore. I took benedryl to
prevent an attack in me personally.

Product:
Nag Champa incense sticks.
Label information: Nag Champa Agarbatti Satya Sai Baba. Mfrs. Shrinivas
Sugandhalaya(BNG)LLP.1/9,8th Cross, Magadi Road, Bengaluru-560023, India. Certified green
product. Export Quality.2021 Series. Hand Rolled in India. UPC 8904245400491.Warning: insist for this label to avoid imitation buy from reputed dealers only. Earth. Contains seals with hologram over each side of the box with official logo. NetWt.40g. Quality assurance labels are not actual stickers demonstrating actual checks, but are instead printed onto the package to appear as if they were actual quality assurance stickers and are offset with a white background to trick a consumer. There are three which areas follows. Fake QA sticker1: Quality Assurance Management ISO 9001(check mark symbol)
Fake QA sticker2: Environmental Management ISO 14001(check mark symbol) Fake QA sticker 3: Occupational Health &
Safety OHSAS 45001 (check mark symbol).
Customer care number+917022000111

Item purchased at Archimage. Not their fault. They only buy reputable authentic items and this has to be a bad or contaminated batch here. | Symptoms: Nausea, Other
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