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Recent Interesting Reports
Chester, PA, USA
April 29, 2021 5:31 PM
“I ordered a "Battery-Powered Wood Cutter x 1". The picture of my order was very similar to the one next to this report I am making. They sent me an email back telling my they had two options on the page and I chose to pay for some chain looking thing that looks like you can kill someone with it. And... they refuse to give me my money back. I have the order, email correspondence and photos of the product I ordered. They advertise in very large photos one thing and then have a very small photo in the corner of something else. You had no idea was even there. Until you don't get what you ordered, but in stead you get the tiny thing in the corner. I can supply all this to you if you can stop these thieves from continuing there false business practices. ”
Symptoms: Other Skin Rash
Horseheads, New York, USA
May 6, 2021 12:47 AM
“This was all after waiting the 20 minutes before leaving within 5 minutes after getting in my car I felt a burning in my right foot that within 20 minutes was burning both feet and legs all the way. Burning in my body from the waste down for 4 hours then severe rash all over my body except my face. ”
April 30, 2021 6:01 PM
“Company name: Acella Pharmaceuticals, LLC
Brand name: Acella
Product recalled: NP Thyroid (Thyroid Tablets, USP)
Reason of the recall: Sub potency
FDA Recall date: April 30, 2021
Recall details: Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 belo... w of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).
Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.
There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations, or cardiac arrhythmia.
To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count and 7-count bottles. See product images below. To best identify the product, the NDC’s, Product Description, Lot Numbers, and Expiration Dates are listed on the link below.
These lots were distributed nationwide in the United States to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Acella is proactively notifying its consignees to discontinue distribution of the above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
Consumers with questions about the recall can email Acella Pharmaceuticals at email@example.com or contact our representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. 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 ”
Symptoms: Nausea Headache Dizziness Fatigue Body Ache Soreness
Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA
April 21, 2021 6:01 PM
“Day 1 after vaccination my symptoms were a headache, nausea, medicine head, dizzy spells and alittle fatigue. Day 2 after my second dose. My symptoms include the following, sore painful arm, nausea, slight headache, medicine head, body & muscle aches, lymph nodes appeared to be inflamed which caused... my ears to hurt. Felt like I had a mild case of the flu. Been miserable and missing 2 days of work because of this. ”
Alameda, CA, USA
May 4, 2021 2:10 PM
“I bought a battery powered woodcutting saw from Kenyak. I recieved a chain with two rings. How can we stop these people. I bought this a couple months ago and today the ad is still running on USA today. Please help. Please stop these people. The add is still on USA today ”
Symptoms: Vomiting Other
Yulee, FL, USA
April 27, 2021 9:13 AM
“We gave our dog the Dreambone Dino Chews on Sunday. On Tuesday we noticed he was wanting to go into his kennel and sleep. Tuesday evening he was acting odd with jerking movement, sticking his tongue out, oddly staring at the ceiling and refusing to drink water. We immediately took him to the vet whe... re they induced vomiting, gave him antibiotics and an IV. He continued to not drink water in his own and show neurological behaviors that our vet said was focal seizures, lip-licking and star-gazing. The Dreambone treats were the only change in his diet. He would not drink water on his own for at least 3 days and he had focal seizures on and off for about 5 days. Do not give your dog any Petmatrix, Spectrum, or Dreambone product. They will poison your beloved pet. They package says they are made in China and when you google the company they are also made in Vietnam. ”
Doctor Visit: Yes
Diagnosis: Doctor visit
May 12, 2021 8:00 PM
“Company name: Dibar Nutricional S. de R.L. de C.V.
Brand name: DIBAR Labs, ProtectoRx
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 12, 2021
Recall details: Company Announcement Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (... “Dibar”) is voluntarily recalling 27 lots of DIBAR Labs Hand Sanitizer packaged in 8oz (8-53090-00301-3 UPC) and 16 oz (8-53090-00302-0 UPC) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 1 and Label 1). Dibar is also voluntarily recalling 2 lots of ProtectoRx Hand Sanitizer packaged in 2oz (Lot Number LDHSN050720) and 16oz (Lot Number LDHSN050820) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 2 and Label 2). These products are being recalled after testing conducted by our firm revealed the presence of methanol.
Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.
To date, the company has not received any reports of adverse reactions related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected bottles of hand sanitizer include a twelvedigit lot code printed on the bottle near the base.
The products can be identified by the label, scent, and lot code provided in the table at the end of this release. These products were distributed nationwide in the USA through S.E.N.D. LLC and its customers (Click in the link below Table 1). Products labeled as ProtectoRx Hand Sanitizer were distributed in Puerto Rico through PR TRADING LLC and its customers (Click in the link below Table 2.). Dibar Nutricional S. de R.L. De C.V., has notified its direct distributors by a letter with confirmatory email and asked that they remove the recalled products from commerce immediately if they still had any in inventory. Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase.
Consumers with questions regarding this recall can contact our Commercial Offices, +52 443-314-5369, M-F, during business hours 9:00 a.m. – 6:00 p.m. ET and/or email us to QA@dibarlabs.com. 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.
- 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. (Table 1. Lots distributed to S.E.N.D. LLC and its customers)
Check the full recall details on fda.gov
Source: FDA ”
Kingston, ON, Canada
April 29, 2021 10:25 AM
““I purchased this Stihl chain saw on Feb 4, 2021 from Blackcass but to date all I received was a chain with grips. I would like my saw as ordered or a full refund and they pay for shipping. ”
Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially weakened elastic, USA
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... nationwide 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 ”
Kibbles and bits bistro, Walmart Supercenter, South Oates Street, Dothan, AL, USA, Walmart Supercenter, South Oates Street, Dothan, AL, USA
Walmart Supercenter, South Oates Street, Dothan, AL, USA
April 18, 2021 10:04 AM
“I have 2 sick, A week and a half ago Née bag of Kibbles and bits bistro and the Melody Just started about a week and a half ago now I have two dogs sick one with an IV in the hospital ”
Doctor Visit: Yes