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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 See Less

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October 11, 2021 – Tuffy's Pet Foods is issuing a voluntary recall of approximately 1,600 cases of Pure Vita Salmon Entree Dog Food in a Tetrapak carton following notification from the product manufacturer of potentially elevated levels of Vitamin D. No illnesses or injuries have been reported... See More from consumers to date.

Consuming elevated levels of vitamin D in dog food can cause adverse reactions in dogs of all sizes, including symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. When ingested at excessive levels, vitamin D can lead to serious health issues in dogs including renal dysfunction. While no reports of illness or injury have been reported from consumers to date, Tuffy’s is acting out of an abundance of caution and is removing the specific lots of product listed below from distribution.

Consumers should stop feeding the product listed below to their pets immediately. Tuffy’s recommends consumers whose dogs have consumed the potentially affected product and are exhibiting any of the above-mentioned symptoms contact their veterinarian.

- Pure Vita Salmon Entrée Dog Food TetraPak (12.5 oz. per carton). UPC: 0 73893 96202 1. Lot numbers: 0629101N1 /
0901101N1. Best By dates: 29 Jun 2023 / 1 Sep 2023.

The recalled product was distributed exclusively within the United States to distributors and retail stores.  The recalled product is limited to Pure Vita Salmon Entrée Dog Food in a Tetrapak carton, bearing UPC Code "0 73893 96202 1" (found on side of the carton).  Products included in the recall are identified by the "Best by Dates" and “Lot Numbers” (found on the top of the carton) as listed above. No other Pure Vita dog or cat foods, or treats are affected by this announcement.

Consumers who purchased the Pure Vita Salmon Entrée dog food product subject to this voluntary recall (as identified above) are urged to return the product to their retailer for a full refund.

For consumer information or questions regarding this voluntary recall, please contact Tuffy’s Pet Foods, Inc. at (800) 525-9155 from Monday-Friday, 8:00am-5:00pm Central Time

Company name: Tuffy’s Pet Foods, Inc.
Brand name: Nutri Source
Product recalled: Pure Vita Salmon Entrée Dog Food
Reason of the recall: Elevated Levels of Vitamin D
FDA Recall date: October 12, 2021

Check the full recall details on fda.gov

Source: FDA See Less

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Over recent weeks, SafelyHQ received a surge of reports from our community citing lost and delayed packages from the US Postal Service specifically citing packages that routed through Teterboro NJ Distribution Center. The New York Post - which follows and identifies signals from our community followed up... See More on our story and reported on it yesterday.

If you have any health, safety, or community issue, including issues with delivery services, report it to SafelyHQ. Reporting will help identify and bring attention to common problems that impact friends, family, and our communities at the local and national level.

Read the full NY Post story here: nypost.com See Less

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I mailed out a Shutterfly book to my cousin in Fl, from where I live in NY on July 1st and the last known tracking of it was 4 days later in aTeterboro, NJ. It’s a bright orange package, you can’t miss! As of today Oct. 15th,... See More it’s still missing. In mid Sept. Shutterfly was nice enough to print a second book, which I had sent direct from Shutterfly to Fl. My cousin never got that book either. After contacting Shutterfly again, they were kind enough to send out a 3rd book, which she finally got. For the first package, I sent out, I put in a missing claim with USPS and continue to get emails saying they are still working on finding my missing package. What a joke. See Less

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This is the 2nd package that just arrives at teterboro and just stops moving what’s the point of charging for next day air if you can’t get it done .. worse thing about this is that’s it’s anxiety medication i desperately need See Less

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FROMM FAMILY FOODS is issuing a voluntary recall of approximately 5,500 cases of Fromm Shredded can Entrée dog food due to potentially elevated levels of Vitamin D.

Consumers should stop feeding the products listed below to their dogs. Potential adverse reactions could occur in all size dogs. ... See More No reports of illness or injury have been reported from consumers to date, however Fromm management has determined it is prudent to pull these four lots out of distribution.

Affected recalled products were distributed at neighborhood pet stores nationwide.

Products are packaged in 12 oz. cans with Best By Date 08/2024. A full list of affected products is:
- Four-Star SHREDDED BEEF IN GRAVY ENTRÉE food for dogs, 12 cans per case, 11877, 12 oz. per can, UPC: 7270511876, Best By Date 082024
- Four-Star SHREDDED CHICKEN IN GRAVY ENTRÉE food for dogs, 12 cans per case, 11881, 12 oz. per can, UPC: 7270511880, Best By Date 082024
- Four-Star SHREDDED CHICKEN IN GRAVY ENTRÉE food for dogs, 12 cans per case, 11879, 12 oz. per can, UPC: 7270511878, Best By Date 082024
-Four-Star SHREDDED TURKEY IN GRAVY ENTRÉE food for dogs, 12 cans per case, 11883, 12 oz. per can, UPC: 7270511882, Best By Date 082024

Dogs ingesting elevated levels of Vitamin D may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D when consumed at very high levels can lead to serious health issues in dogs including renal dysfunction. Consumers who have dogs that have consumed any of the affected products and are exhibiting these symptoms should contact their veterinarian.

Check the full recall details on fda.gov

Company name: Fromm Family Foods
Brand name: Fromm Four-Star Nutritionals
Product recalled: Shredded Entrée canned dog food
Reason of the recall: Elevated levels of Vitamin D
FDA Recall date: October 01, 2021

Source: FDA See Less

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Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility... See More assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.

Intravenous administration of a non-sterile drug could result in serious infections ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides, and wound infection which may be life-threatening. The possibility of a breach in sterility assurance in distributed products, while not confirmed, cannot be eliminated. No batches of the product have been identified as containing microorganisms. To date, IntegraDose Compounding Services has not received reports of any adverse events associated with this issue for these lots.

- Cefazolin 2 gram in 20 mL syringe for injection. (See link below for a detailed list of Lots)
- Cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection. (See link below for a detailed list of Lots)

Cefazolin is an antibiotic and the products are packaged in zip-locking bags containing ten units. The lots were distributed nationwide in the USA to hospitals from 8/12/21 to 9/15/21. IntegraDose Compounding Services has initiated an investigation to determine the root cause and corrective and preventative actions.

IntegraDose Compounding Services has notified its direct customers via a recall letter and is arranging for the impacted product to be returned. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately.

Consumers with questions regarding this recall can contact IntegraDose Compounding Services by phone at (612-672-5216) on Monday - Friday, 8:00 AM – 4:00 PM CDT.

Company name: IntegraDose Compounding Services, LLC
Brand name: IntegraDose Compounding Services, LLC
Product recalled: Cefazolin
Reason of the recall: Lack of sterility assurance.
FDA Recall date: September 21, 2021

Check the full recall details on fda.gov

Source: FDA See Less

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My order has shown 'package in transit, running late" since 9/7. See Less

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Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level.  Coppertone has identified the presence of benzene in these lots of products Twelve lots of... See More Coppertone spray products are impacted by this voluntary recall, specifically:

- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . Lot: TN0083J UPC: 72140028817. Manufacturing Date: 44470.
- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . TN0083J: TN0083K 72140028817: 72140028817. Manufacturing Date: 44501.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN0083K: TN00854 72140028817: 72140028824. Manufacturing Date: 44531.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN00854: TN00855 72140028824: 72140028824. Manufacturing Date: 1/14/2021.
- Product Description: CT SPORT MIN SPF50 SPRAY 5OZ 12S . TN00855: TN008KU 72140028824: 72140028701. Manufacturing Date: 3/15/2021.
- Product Description: CT SPORT MIN SPF50 SPRAY 5OZ 12S . TN008KU: TN008KV 72140028701: 72140028701. Manufacturing Date: 3/16/2021.
- Product Description: CT P&S SPF50 SPRAY 5OZ 12S . TN008KV: TN00BR2 72140028701: 72140028800. Manufacturing Date: 3/31/2021.
- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . TN00BR2: TN009GH 72140028800: 72140028817. Manufacturing Date: 3/31/2021.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN009GH: TN00857 72140028817: 72140028824. Manufacturing Date: 44351.
- Product Description: CT SPORT SPRAY SPF50 1.6OZ 24S . TN00857: TN00BU3 72140028824: 41100005069. Manufacturing Date: 44352.
- Product Description: CT P&S SPF50 SPRAY 5OZ 12S . TN00BU3: TN00CJ4 41100005069: 72140028800. Manufacturing Date: 6/15/2021.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN00CJ4: TN00CJV 72140028800: 72140028824. Manufacturing Date: 6/15/2021.

Benzene is classified as a human carcinogen. Exposure to benzene can occur through inhalation, oral, and skin and it could, depending on the level and extent of exposure, result in an increased risk of cancers including leukemia, and blood cancer of the bone marrow and other blood disorders which can be life-threatening.

Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies.

Out of an abundance of caution, we are recalling certain lots of these specific aerosol sunscreen spray products. To date, Coppertone has not received any reports of adverse events related to this recall.

The voluntarily recalled sunscreen spray products are packaged in aerosol cans. The products were distributed nationally in the United States through various retailers. Consumers should stop using these specific Coppertone aerosol sunscreen spray products and dispose of them appropriately.

Coppertone is also notifying its retailers by letter and is arranging for returns of all voluntarily recalled lots of sunscreen spray products. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these aerosol sunscreen spray products.

The FDA and other medical authorities recognize the public health benefits of sunscreens and strongly advise the use of sunscreen along with other protective measures from the sun.

Company name: Coppertone, owned by Beiersdorf
Brand name: Coppertone
Product recalled: Coppertone aerosol sunscreen spray products
Reason of the recall: Presence of benzene
FDA Recall date: September 30, 2021

Check the full recall details on fda.gov

Source: FDA See Less

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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 See Less

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