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Updated: March 22, 2023 4:00 PM
Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers)... See More in the United States from June 2022 to October 2022. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.
The NDC. Lot Number. Expiration Date. and Packaging Configuration details for Dabigatran Etexilate Capsules that are subjected to this recall are shown in the image below.
In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Ascend Laboratories LLC.
Brand name: Ascend Laboratories
Product recalled: Dabigatran Etexilate Capsules, USP
Reason of the recall: Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: March 22, 2023
Source: fda.gov See Less
Kaytee Products Inc. is voluntarily recalling one lot of Kaytee® Wild Bird Food Birders’ Blend, 8 lb. bag, UPC 0 71859 02711 1, Lot Number PennPak1 102022 933, best buy date of 041224, due to potentially elevated levels of Aflatoxin above the acceptable limit. The affected product... See More was shipped to ACE Hardware Distribution Centers in AL, FL, and GA, which service neighborhood hardware stores in the Southeastern United States.
The recalled product is:
- Kaytee® Wild Bird Food Birders’ Blend, 8 lb, UPC: 0 71859 02711 1, Lot N PennPak1 102022 933, BEST BY 041224. The wild bird product was packaged in clear plastic bags.
On March 13, 2023, the Georgia Department of Agriculture notified Kaytee Products Inc. that after conducting a routine laboratory analysis of the product, Lot PennPak1 102022 933 located on the bottom right corner of the front of the 8 lb. bags of Kaytee® Wild Bird Food Birder’s Blend was found to contain elevated levels of Aflatoxin.
Aflatoxin is a naturally occurring by-product from the growth of Aspergillus flavus and can be harmful to wild birds if consumed in significant quantities. No illnesses have been reported in association with this product to date and no other Kaytee products are affected.
Consumers who have purchased the recalled wild bird product should return it to the place of purchase for a full refund. Retailers who received the affected wild bird product have been contacted and asked to pull them from their inventory and shelves.
Company name: Kaytee Products Inc.
Brand name: Kaytee
Product recalled: Wild Bird Food Birders’ Blend
Reason of the recall: Potential Elevated Levels of Aflatoxin
FDA Recall date: March 20, 2023
Source: Ffda.gov See Less
Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator.... See More The Life2000 system is manufactured by Hillrom, which was acquired by Baxter in late 2021. The Life2000 System is distributed in the United States.
Low oxygen saturation may lead to symptoms such as shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death, life-threatening events or permanent impairment may occur if patients or caregivers do not recognize lower oxygen levels. Scenarios that could lead to oxygen desaturation include hoses that are kinked or have excessive moisture; modified, extended or loose/disconnected tubing; oxygen liter flow from the concentrator that has fallen below the prescribed level while using the Life2000 system; and/or non-compliance with recommended cleaning and maintenance of the Life2000 system and oxygen concentrator. Baxter has received reports of patient desaturation that required hospitalization. Based on analysis to date, no deaths have been reported related to this issue.
As described in the Urgent Medical Device Correction issued on January 25, 2023, patients can continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements as detailed in the patient letter and Instructions for Use for both the Life2000 Ventilation System and third-party oxygen concentrators. These actions will help ensure the best oxygen delivery with the Life2000 system when used with a third-party oxygen concentrator. Baxter is continuing to monitor and investigate reports received and is currently investigating improvement opportunities.
Baxter will issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue. This Urgent Medical Device Correction applies to all Life2000 Ventilation Systems used with an oxygen concentrator, including the Life2000 Ventilator Packaged (BT-20-0002); the Life2000 Ventilator Packaged A (BT-20-0002A); the Life2000 System AC Package (BT200007); the Breathe Life2000 Ventilator PA (BT-20-0007); the Life2000 System HC Package (BT200011); the Breathe Technology Life2000 VE (BT-20-0011); and the Life2000 Ventilator V6.X (MS-01-0118).
Baxter is voluntarily issuing this Urgent Medical Device Correction and the U.S. Food and Drug Administration has been notified of this action.
Company name: Baxter International Inc.
Brand name: Life2000
Product recalled: Life2000 Ventilation System
Reason of the recall: Potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator
FDA Recall date: March 10, 2023
Source: fda.gov See Less
524
Purina Pro Plan Veterinary Diets EL Elemental - recalled due to elevated Ingredient level, USA
2 weeks ago
Nestlé Purina PetCare Company is expanding its voluntary recall of Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food due to a supplier error resulting in potentially elevated levels of vitamin D in two additional product lots, which precede the production dates of... See More the previously recalled lots. The original announcement was made on February 8, 2023. No other Purina pet care products are affected.
The expansion comes following an investigation prompted by Purina that uncovered new information about a production error from a U.S. supplier that was made only to this specific formula and resulted in potentially elevated levels of vitamin D. Vitamin D is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the level of vitamin D and the length of exposure. Vitamin D toxicity may include vomiting, loss of appetite, increased thirst, increased urination, and excessive drooling to renal (kidney) dysfunction. A list of the additional impacted product is below. Bags of PPVD EL with the UPC Code and Production Code below should be immediately discarded.
Product: Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL)
UPC Code (*First 8 characters equal to): 38100 19190 – 8 lb / Production Code: 2213 1082 (NEW)
UPC Code (*First 8 characters equal to): 38100 19192 – 20 lb / Production Code: 2214 1082 (NEW)
The affected dry dog food was distributed throughout the United States by prescription only through veterinary clinics, Purina Vet Direct, Purina for Professionals, and other select retailers with the ability to validate a prescription.
Pet owners who purchased bags of the product listed above are asked to immediately stop feeding and throw it away in a container where no other animals, including wildlife, can get to it. If signs such as weight loss, excessive drooling, vomiting, loss of appetite or increased thirst or urination have occurred in their dog while eating this diet, pet owners should contact their veterinarian.
Veterinary and other retail partners should remove and destroy the affected product from their inventory.
In case your pet experiences harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Nestle Purina PetCare Company
Brand name: Purina
Product recalled: Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food
Reason of the recall: Potential Elevated Ingredient Level
FDA Recall date: March 10, 2023
Source: fda.gov See Less
524
Omega-3 Supplements for cats and dogs - recalled due to elevated levels of vitamin A, USA
2 weeks ago
Stratford Care USA, Inc of Odessa, Florida is recalling multiple brands of Omega-3 Supplements for cats and dogs due to potentially elevated levels of Vitamin A. Vitamin A is an essential nutrient for dogs; however, ingestion of elevated levels can lead to health issues depending on the... See More level of Vitamin A and the length of exposure. Omega-3 Supplements for cats and dogs was distributed throughout the United States in Veterinary Clinics, Distribution Centers, Retail Stores, and Online Market Places such as Amazon and Chewy.
Vitamin A toxicity may include general malaise, anorexia, nausea, peeling skin, weakness, tremors, convulsions, paralysis, and death. Stratford Care USA, Inc is taking this action after receiving a single Serious Adverse Event from a sole consumer regarding their dogs’ exhibiting signs of Vitamin A toxicity after consuming the supplement. This is the only Adverse Event to date.
Currently, Stratford Care USA, Inc in collaboration with the FDA is removing all products with these lot numbers from the market. No other Stratford Care USA, Inc products are affected. The white plastic container containing 60 soft gels has the marking on the bottom of the container that states “lot 31133 EXP 04/13/23” and “lot 30837 EXP 10/26/22”, this product has been private labeled under various brand names.
Affected products:
- Brand Name: All Creatures Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: All Veterinary Supply, INC. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Jungle Pet. Product Name: Skin+Coat Omega-3 Soft Gels. UPC (If Applicable): 85000395223.
- Brand Name: Animal Medical Clinic. Product Name: Omega V3 Softgels. UPC (If Applicable): 169682510808.
- Brand Name: Animal Medical Clinic Melbourne Beach. Product Name: Omega V3 Softgels. UPC (If Applicable): .
- Brand Name: Animal Care Hospital. Product Name: Omega-3 Fatty Acid Max Strength Soft Gels. UPC (If Applicable): NA.
- Brand Name: Animal Medical Center. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Barnes Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Brentwood Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Cherokee Trail Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Clinton Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Clyde’s Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Coastal Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Columbia Hospital For Animals. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Compassion Veterinary Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Doc Ladue’s. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Dogwood Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Doral Centre Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Eagles Landing Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Pet Health Solutions. Product Name: Omega Caps. UPC (If Applicable): 814087005489.
- Brand Name: SPCA of North Brevard. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): .
- Brand Name: LaVale Veterinary Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Twin Maples. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: University Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Venice Pines Veterinary Clinic. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Lake Dow Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: MVH Mann Veterinary Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: All Paws Animal Clinic Royal Palm Beach. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Bottle Tree Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Brookwood Veterinary Clinic. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Cleveland Park Animal Hospital. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Crown Heights Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Eagle’s Landing Veterinary Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: LVH Veterinary. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Mt Orab Veterinary Clinic. Product Name: Dr. Hayes’s Omega-V3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: Oak Tree Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Patterson Veterinary Hospital – Mason. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Prospect Heights Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Smyth County Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Stateline Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: The Pet Clinic of Urbana, LLC. Product Name: Omega-V3 Softgel. UPC (If Applicable): NA.
- Brand Name: Valdosta Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Viking Community Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Westbrook Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: My Pet Hospital. Product Name: Omega-3 Soft Gels. UPC (If Applicable): NA.
- Brand Name: North Shore Animal League America. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: NPC Northgate Pet Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Northwest Tennessee Veterinary Services. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Pawstruck.com. Product Name: Omega-V3 Soft Gels. UPC (If Applicable): 850005963080.
- Brand Name: Perry Animal Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Pleasant Plains Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Seiler Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Stratford Animal Health. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Summerfields Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: SensoVet Animal Health Wellness. Product Name: Advanced Omega-3 Softgel. UPC (If Applicable): NA.
- Brand Name: University Animal Hospital. Product Name: Omega-V3 Softgels\. UPC (If Applicable): NA.
- Brand Name: Vet4Bulldog. Product Name: V4B Bully Fish oil omega-3 EFA. UPC (If Applicable): 603981565911.
- Brand Name: Waggin’ Wheel Vet Clinic. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Wellsboro Small Animal Hospital Veterinary Medical Center. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Wickham Road Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
- Brand Name: Wilton Manors Animal Hospital. Product Name: Omega-V3 Softgels. UPC (If Applicable): NA.
In case your pet experiences harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Stratford Care USA, Inc
Brand name: Multiple brands
Product recalled: Omega-3 Supplements for cats and dogs
Reason of the recall: Potential elevated levels of Vitamin A
FDA Recall date: March 10, 2023
Source: fda.gov See Less
524
Dr Rima Recommends Nano Silver dietary supplement - recalled due to unsubstantiated health claims, USA
3 weeks ago
CUSTOMERS OF NATURAL SOLUTIONS FOUNDATION (the “Foundation”) This is to inform you of a voluntary product recall involving the following Foundation product (the “Product”) “DR. RIMA RECOMMENDS NANO SILVER 10 PPM” The Product label is depicted for your reference and ease in identifying the Product. This recall... See More has been initiated because the Product is labeled as a dietary supplement that, in the opinion of the government, makes unsubstantiated health claims that the product will prevent, treat, or cure COVID-19. It is the government's position that consumers who use this product instead of seeking timely medical treatment run the risk of serious, life-threatening health consequences.
The Product was sold January 22, 2020 to December 27, 2021. Please examine your inventory to see whether or not you possess any Product subject to this recall and immediately cease distribution. If the Product has been further distributed, kindly identify all such persons so that we can make them aware of the Product recall. You are encouraged to notify your customers that the Product recall is occurring, and to provide them with a copy of this Notice. This recall should be carried out to the consumer level.
Company name: Natural Solutions Foundation
Brand name: Dr Rima Recommends
Product recalled: Dr Rima Recommends Nano Silver 10ppm dietary supplement
Reason of the recall: Product makes unsubstantiated health claims to prevent, treat, or cure COVID-19
FDA Recall date: March 08, 2023
Source: fda.gov See Less
524
Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. Product... See More was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. Amazon Marketplace, Etc.).
Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles.
The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. The product can be identified by the labels attached.
Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.
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.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Pharmedica USA LLC
Brand name: Purely Soothing
Product recalled: 15% MSM Drops
Reason of the recall: Non-sterility
FDA Recall date: March 03, 2023
Source: fda.gov See Less
524
Apotex Brimonidine Tartrate Ophthalmic Solution, 0.15% - recalled due to lack of sterility, USA
3 weeks ago
Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. This recall is being initiated out of an abundance of caution due to cracks that have developed... See More in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events. These lots were distributed nationwide in the USA between April 05, 2022 to February 22, 2023.
Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% can be identified by NDC numbers stated on the carton and label of the product. The lot number and expiry date are located on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode.
-Affected products:
Product: Brimonidine Tartrate Ophthalmic Solution
Strength: 0.15%
Pack Size: 5 mL
NDC #: 60505-0564-1
UPC Code on Carton: 360505056415
UPC Code on Bottle: (01)0(03) 60505056415
Lot #: TJ9848 Expiry Date: 02/2024
Lot #: TJ9849 Expiry Date: 02/2024
Lot #: TK0258 Expiry Date: 04/2024
Lot #: TK5341 Expiry Date: 04/2024
Product: Brimonidine Tartrate Ophthalmic Solution
Strength: 0.15%
Pack Size: 10 mL
NDC #: 60505-0564-2
UPC Code on Carton: 360505056422
UPC Code on Bottle: (01)0(03) 60505056422
Lot #: TK0261 Expiry Date: 04/2024
Product: Brimonidine Tartrate Ophthalmic Solution
Strength: 0.15%
Pack Size: 15 mL
NDC #: 60505-0564-3
UPC Code on Carton: 360505056439
UPC Code on Bottle: (01)0(03) 60505056439
Lot # TK0262 Expiry Date: 04/2024
Patients who have received the identified lots or have questions regarding this recall should contact their pharmacy. They should immediately contact their health care provider for medical advice and return the identified lots to Inmar Rx Solutions.
Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy should return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately.
In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Apotex Corp.
Brand name: Apotex
Product recalled: Brimonidine Tartrate Ophthalmic Solution, 0.15%
Reason of the recall: Potential lack of sterility.
FDA Recall date: March 02, 2023
Source: fda.gov See Less
524
Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised. The product was distributed nationwide in the United States, and... See More by Delsam through internet retail sites.
Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) is used as an eye lubricant and to relieve dryness of the eyes.
The affected product is packaged in a white aluminum tube within a paper carton. The product can be identified by the photos provided below. Delsam Pharma’s NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3. Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop any use and discard the product safely and appropriately.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Global Pharma Healthcare
Brand name: Delsam Pharma’s
Product recalled: Artificial Eye Ointment
Reason of the recall: Due to possible microbial contamination
FDA Recall date: February 24, 2023
Source: fda.gov See Less
524
Bindle Bottle LLC of Carlsbad, CA, is recalling its Bindle Bottles because they may contain an area of exposed lead located in the bottom storage compartment of the bottle. Unpackaged food stored in the bottom storage compartment of the bottle may have been adulterated by the lead... See More and could pose health problems to people or animals eating that adulterated food. The recalled Bindle Bottles were distributed nationwide via bindlebottle.com, amazon.com, promotional distributors, and in retail stores. No illnesses have been reported to date in connection with this problem.
The product comes in four sizes: 32 oz, 24 oz, 20 oz, and 13 oz. Bindle Bottle is also recalling the 24 oz bottle that is part of the Puppy Pack.
People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems. Clinical signs in dogs with acute lead poisoning may include lethargy, anorexia, behavioral changes, ataxia (wobbly gait), tremors, and seizures.
Reports by Lead Free Mama and Consumer Reports led the firm to have the bottle tested. The recall was initiated after analytical results revealed that the small, 0.4” diameter soldering dot in the bottom storage compartment contained lead. Subsequent investigation indicates the problem was caused by a lack of a cover or barrier to the exposed soldering dot. Production of Bindle Bottles has been suspended and will be overhauled going forward, eliminating the presence of exposed lead anywhere on future products. As part of the recall, consumers who purchased a Bindle Bottle are eligible to receive at-home repair kits to rectify the issue. These repair kits can be obtained by filling out a form at bindlebottle.com/pages/recall.
In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Bindle Bottle LLC
Brand name: Bindle Bottle LLC
Product recalled: Bottles
Reason of the recall: Adulterated by lead
FDA Recall date: February 23, 2023
Source: fda.gov See Less
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FE
F.............5
There is a number on The gummies it is 884-677-0094 you can call them and they will stop any orders. This was apparently a free trial that I didn't sign up for. But they did take care of it for me
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