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Hospira Aminosyn II, 15% - recalled due to visible particulate matter presence, USA

1 month ago

United States

Company name: ICU Medical, Inc.
Brand name: Hospira
Product recalled: Aminosyn II, 15%, An Amino Acid Injection, Sulfite
Reason of the recall: Presence of visible particulate matter
FDA Recall date: September 07, 2021
Recall details: ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. 

ICU Medical became aware of this issue while inspecting retain samples as part of routine process. Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. 

To date, ICU Medical, Inc. has not received reports of adverse events or illnesses related to this recall. Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. 

Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce the breakdown of organic or inorganic materials, such as proteins, sugars, fatty acids, etc. in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to prevent or reverse excreting more nitrogen than is being taken in in patients where the intestinal tract, by the oral, surgical opening into the stomach for the introduction of food or surgical procedure for a feeding tube routes cannot or should not be used and gastrointestinal absorption of protein is impaired. 

Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The product is for human use only. ICU Medical acquired this product from Hospira, a Pfizer company; therefore, the affected product contains a Hospira NDC number and a Hospira label. The affected product lot, manufactured in the U.S. by ICU Medical in November 2020, is listed below:  

- Aminosyn® II 15% An Amino Acid Injection, Sulfite-Free. NDC: 0409-7171-17. Catalog Number: 07171-17. Lot Number: 4989094. Expiration Date: 01-Apr-2022. Configuration: Pharmacy Bulk. Package 2-liter. Flexible. Container. Manufacture Date: November 2020. Distribution Dates: January 2021 – March 2021.

ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products.

Hospitals/distributors that have a product that is being recalled should stop use/further distribution and return to the place of purchase.

Customers with questions regarding this recall can call ICU Medical at 1-844-654-7780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Check the full recall details on fda.gov

Source: FDA

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Related Reports

Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV, or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. To date, Bayer... See More has no known reports of adverse events related to this recall.

Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow, and blood disorders that can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally.

The affected Lotrimin® and Tinactin® spray products are over-the-counter antifungal products, sold individually or in combo packs.

The impacted products are:
- Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
- Lotrimin® AF Athlete's Foot Liquid Spray
- Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
- Tinactin® Jock Itch (JI) Powder Spray
- Tinactin® Athlete’s Foot Deodorant Powder Spray
- Tinactin® Athlete’s Foot Powder Spray
- Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at the link below. There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada, and Mexico through a variety of retail channels.

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

Check the full recall details on fda.gov

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

Source: FDA
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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
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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
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Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be... See More super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.

Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.

Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall.

- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle. NDC: 52565-009-50. Lot number/Expiration: 13262 / 03/2022 | 14217 / 08/2022 | 13058 / 02/2022 | 13768 / 05/2022. NDC: 63739-997-64. Lot number/Expiration: 16306 01/2024

The product is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract and is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50 and 63739-997-64. The product can be identified by the following labeling: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). Product was distributed at the wholesale and retail distribution levels in the US and Canada.

Teligent Pharma, Inc. is notifying its distributors via Fed-Ex and is arranging for return of all recalled products.

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

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

Check the full recall details on fda.gov

Source: FDA
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Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg
Reason of the recall: API batches above the specification limit for the impurity, N-nitrosoirbesartan
FDA Recall date: October 14, 2021
Recall details: Baltimore, Maryland, October 14, 2021:... See More Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.

Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.

Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021. Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide. Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021. The recalled lots are included in the link below.

Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Irbesartan and hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021. The recalled lots are included in the link below.

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

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

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

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

Check the full recall details on fda.gov

Source: FDA
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Shipment was supposed to arrive Friday.  Now I received the following message : Your shipment has potentially been delayed due to emergency or other conditions at 6:46 pm on October 17, 2021. | Symptoms: Other See Less


I paid $7.95 to send a letter via USPS Priority Mail from Short Hills, New Jersey to Arlington, VA. I mailed the item via Priority Mail on September 28, 2021 and the receipt stated it would arrive by October 1, 2021. It did not arrive until October... See More 9, 2021 - eleven days later! I took my receipt to the Short Hills post office and was referred to a supervisor, who told me I could not get a refund because two-day Priority Mail did not provide a "money back guarantee" if the item was delivered late. See Less
472


Three packages from mid-Sept./early Oct. are now backlogged at Teterboro, NJ and nothing updates from "being processed" from Teterboro. So disappointing. I will not order anything further that has to route through this entity. People wanting Christmas gifts better pick them up locally. It may be next... See More year, if at all, when packages arrive. See Less
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Hundreds Without Power For Eight Hours Saturday In Walnut Hill And Bratt Area.

Source: northescambia.com
Source publication date: 2021 10 17 See Less
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Hawaii Island crews responding to Ainaloa/Pahoa outage; 2101 customers without power  on Saturday, Oct. 16. - expected electricity to be restored by 9:30 p.m. Saturday.

Source: khon2.com
Source publication date: 2021 10 16 See Less


Recent Interesting Reports

Company name: Eli Lilly and Company
Brand name: Lilly
Product recalled: Glucagon Emergency Kit
Reason of the recall: Loss of potency
FDA Recall date: September 26, 2021
Recall details: Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit... See More for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form.

The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.

Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. The product is packaged in a kit containing 1mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. The affected Glucagon Emergency Kit lot is D239382D and the expiration date is April 2022 (label expiry date: 04 2022). The lot number can be found on the label of the kit as well as the vial (refer to the photos provided below – Appendix A). The lot was distributed nationwide to wholesalers and retailers.

Wholesalers and Distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately.

Instructions for Wholesalers and Pharmacists: If you have distributed the recalled product, please notify any accounts or additional locations which may have received product from the recalled lot from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

Instructions for Consumers: Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center at 1-800-545-5979 for return and replacement instructions for the product (hours of operation are Monday- Friday, 9AM – 7PM EST) and should contact their health care provider for guidance. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. APPENDIX A The Lot Number is found on the kit and vial labels as can be seen in the example label below. 

Check the full recall details on fda.gov

Source: FDA
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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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Shipment was supposed to arrive Friday.  Now I received the following message : Your shipment has potentially been delayed due to emergency or other conditions at 6:46 pm on October 17, 2021. | Symptoms: Other See Less


Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg
Reason of the recall: API batches above the specification limit for the impurity, N-nitrosoirbesartan
FDA Recall date: October 14, 2021
Recall details: Baltimore, Maryland, October 14, 2021:... See More Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.

Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.

Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021. Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide. Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021. The recalled lots are included in the link below.

Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Irbesartan and hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021. The recalled lots are included in the link below.

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

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

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

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

Check the full recall details on fda.gov

Source: FDA
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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
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I was a premium TokyoTreat subscriber for 6 months, 35$/month, I got only 2 boxes, first when I subscribed, last one after I unsubscribed. Looks like real scam to me, they steal my money 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
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Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV, or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. To date, Bayer... See More has no known reports of adverse events related to this recall.

Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow, and blood disorders that can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally.

The affected Lotrimin® and Tinactin® spray products are over-the-counter antifungal products, sold individually or in combo packs.

The impacted products are:
- Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
- Lotrimin® AF Athlete's Foot Liquid Spray
- Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
- Tinactin® Jock Itch (JI) Powder Spray
- Tinactin® Athlete’s Foot Deodorant Powder Spray
- Tinactin® Athlete’s Foot Powder Spray
- Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at the link below. There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada, and Mexico through a variety of retail channels.

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

Check the full recall details on fda.gov

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

Source: FDA
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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
5.1K


HA
Hate USPS
I wonder if we could all group together and file a class action lawsuit. I saw another post here with two tracking #s stuck from October 1st and Sept 28th that haven’t moved yet.
Reply 2 days ago