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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Boil Water Advisory, Herkimer, NY

March 3, 2021 12:00 PM

Herkimer, 13350 New York, United States

A boil water advisory was issued for Herkimer, NY on Mar 3rd.

Source: timestelegram.com

Reported By SafelyHQ.com User

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Recent Interesting Reports

March 30, 2021 10:00 AM

“Company name: Bit & Bet LLC
Brand name: Thumbs Up 7
Product recalled: Blue 69K Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 30, 2021
Recall details: Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7... See MoreBlue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil and tadalafil in Thumbs Up 7 Blue 69K capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take Thumbs Up 7 Blue 69K capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Bit & Bet has not received any reports of adverse events related to this recall. To date, Bit & Bet has not received any reports of adverse events related to this recall This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets in a box labeled with UPC 6 17135 89467 3. Each box contains 10 capsules. The affected lot numbers of Thumbs Up 7 Blue 69K includes all lots. Thumbs Up 7 Blue 69K was distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, e Bay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Bit & Bet LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Thumbs up 7 Blue 69K, which is being recalled should stop using and descard them.

Consumers with questions regarding this recall can contact Bit & Bet LLC by phone at (201) 208-2836 Monday to Friday from 9AM to 5PM or e-mail thumbsup7blue@gmail.com. For more information, please visit www.thumbsup7blue.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to takin or using this drug 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.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

March 26, 2021 7:00 PM

“Company name: Namoo Enterprise LLC
Brand name: PremierZen
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 26, 2021
Recall details: Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling al... See Morel lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil, known as phosphodiesterase (PDE-5) inhibitors, are found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall. Risk Statement: Consumers with underlying medical issues who take PremierZen Black 5000 with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Namoo Enterprise LLC has not received any reports of adverse events related to this recall. The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in card form with one capsule per card and is aware of at least one lot with an expiration date of December 2023. Each pack is black with gold, blue, white and red text. The capsule appears black and is enclosed within clear plastic on the package. The affected lots of PremierZen Black 5000 includes all lots. PremierZen Black 5000 was sold nationwide in the USA via the internet and fulfilled by ebay at www.ebay.com and also fulfilled by amazon at www.amazon.com.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Namoo Enterprise LLC is notifying its customers by this press announcement and by mailing recall letters. Consumers that have PremierZen Black 5000 should stop using and destroy them. Consumers with questions regarding this recall can contact Namoo Enterprise LLC by phone at 201-267-0539, Monday to Friday, 9 A.M. to 5 P.M. EST or email at namooenterprise@gmail.com from Monday to Friday.

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. 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.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

March 23, 2021 5:59 PM

“All I received was the chain and straps not the chain saw how can I get my money back? I am 73 and got cheated out of $29.99 plus tax for a chain saw when all I received was a chain and I want my money back See Less
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April 12, 2021 1:00 PM

“Company name: J. M. Smucker Co.
Brand name: Meow Mix®
Product recalled: Meow Mix® Original Choice Dry Cat Food
Reason of the recall: Potential Salmonella Contamination
FDA Recall date: April 12, 2021
Recall details: Orrville, OH – The J. M. Smucker Co. today announced a limited, voluntary recal... See Morel of two lots of Meow Mix® Original Choice Dry Cat Food (30LB bag) due to potential salmonella contamination. The Company has received no reports of pet illness or adverse reaction and has issued this recall out of an abundance of caution.

The impacted products were sold at select Walmart stores in IL, MO, NE, NM, OK, UT, WI, and WY. No other Meow Mix® products are impacted by this recall. If pet parents have products matching the following description in their possession, they should stop feeding it to their cats and dispose of it immediately. This information can be found on the bottom and back of each bag.

- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1081804. Best If Used By Date: 9/14/2022
- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1082804. Best If Used By Date: 9/15/2022

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 2, 2021 8:00 PM

“Company name: A-S Medication Solutions, LLM
Brand name: A-S Medication Solutions, LLM
Product recalled: Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles contained in Health Essentials Kits distributed by Humana
Reason of the recall: Products contain an incomplete prescription drug lab... See Moreel
FDA Recall date: April 02, 2021
Recall details: Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being conducted to the consumer level. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.

Risk Statement: Use of acetaminophen could be potentially harmful if safety warnings contained on the OTC label are not observed including: liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient. To date, the Company has not received any reports of adverse events related to this recall.

The product is used as a pain and fever reliever. The 100-count bottles labeled with NDC 50090-5350-0 are packaged in white plastic bottles contained in a clear plastic bag with other seasonal products labeled as a Health Essentials Kit. Distribution likely occurred between 1/14/21 and 3/15/21 nationwide in the USA. Expiration dates are either 7/31/22 or 8/31/22. The affected bottles that should be returned contain a short Rx drug label that lacks the full OTC Drug Facts chart.

ASM is also notifying its distributors and customers by mail and is arranging for return of all recalled products. Consumers and distributors that have this product which is being recalled should stop using it and return it in preaddressed return mailers that will be provided by ASM or the distributors.

Consumers with questions regarding this recall can contact ASM by telephone at 847.680.3515 x 236, from 9-5 p.m. CST, or e-mail at anel.figueroa@a-smeds.com. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using this or any drug 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.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

NDC # 50090-5350-0 Lot #s 323206, 323207, 323208, 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335353, 335354, 335355, 335356, 335358, 335359, 335360, 335361, 335362, 335363, 335364, 335365, 335366, 33536, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375, 335376, 335377, 335395, and 352116.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

April 19, 2021 9:01 PM

“Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a... See Morenationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be found using the following link: Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA Consumers who have: Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or timestamp 6 should stop the distribution and use of these and return them to Tenacore LLC.
Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between July 2020 and Feb 2020, should be inspected per the instructions described below to ensure that your device is not impacted. If it is, please return your device to Tenacore LLC.
Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July 2020 through Feb 2021. The following products have been recalled:
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

April 5, 2021 5:00 PM

“Company name: QMART
Brand name: IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 05, 2021
Recall det... See Moreails: Company Announcement Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, QMART has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. The affected lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 include all lots. The product can be identified by the UPC codes in the table below which were distributed via internet and fulfilled by amazon at www.amazon.com. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

March 25, 2021 11:00 AM

“Company name: Zydus Pharmaceuticals Inc.
Brand name: Zydus Pharmaceuticals
Product recalled: Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials
Reason of the recall: Due to Crystalization
FDA Recall date: March 25, 2021
Recall details: Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. i... See Mores voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.

Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells.

To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall. Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients.

The product is packaged in single-dose glass vials and was distributed nationwide in the USA to Cardinal Health, Amerisourcebergen Drug Corporation and Morris & Dickson Company LLC. The affected Acyclovir Sodium Injection, 50 mg/mL lots include the following lot numbers and expiration dates:

- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000155. Expiry Date: Dec 2021. Pack Size: 10x20 mL, Single-Dose Vial pack.

- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000156. Expiry Date: Jan 2022. Pack Size: 10x20 mL, Single-Dose Vial pack.

- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000126. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.

- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000127. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.

Zydus Pharmaceuticals (USA) Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots. Hospitals that have the product which is being recalled should stop using it immediately and call our recall coordinating center at 1-855-671-5023 [Call: 1-855-671-5023] Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST.

Consumers with questions regarding this recall can contact Zydus Pharmaceuticals (USA) Inc. by phone: 1-877-993-8779 [Call: 1-877-993-8779] or by email: medicalaffairs@zydususa.com Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST. 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.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

March 25, 2021 9:01 AM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Antimicrobial Hand Sanitizer
Reason of the recall: Due to microbial contamination
FDA Recall date: March 24, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lot... See Mores listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.

Check the link below for the full list of Durisan Antimicrobial Solutions Hand Sanitizer Sizes and Lot Numbers. To date, no reports of adverse reactions or customer complaints have been reported related to this recall.

The product was packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. Pictures are available in the attached related file.

Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.

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. The product can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.

Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.

Consumers with questions regarding this recall can contact Durisan at 941-351-9114 [Call: 941-351-9114] , 8:30 am - 4:30 pm Eastern time, Monday through Friday or by e-mail at customerservice@durisan.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Covid Vaccine AstraZeneca, Glasgow, UK

Symptoms: Skin Rash Muscle Pain
Glasgow, UK

March 29, 2021 5:06 AM

“After I have my astrazeneca vaccine I had a bad pain in my arm for 4 days but that was not the worst part, I believe the astrazeneca triggered a bad episode of eczema as my skin was fine before the vaccine but shortly after the vaccine my skin started to flair up really badly and I’ve had to go on A... See Morentibiotics. Eczema is caused by an overactive immune response, I believe the astrazeneca triggered a strong immune response and in doing so triggered a outbreak of raw, bleeding skin which became infected and couldn’t Be treated with over the counter creams. I’ve been in severe pain with it for three weeks. I don’t know if it’s a coincidence but I didn’t have any signs of eczema before hand and I was eczema free for over a year. See Less
Reported By SafelyHQ.com User