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Update: Feb 28, 2021 - The Janssen: Pharmaceutical Companies of Johnson & Johnson COVID-19 vaccine has been approved for Emergency Use Authorization by the FDA and will start rolling out in the United States as a Single Dose Covid-19 vaccine.
Janssen: Pharmaceutical Companies of Johnson & Johnson COVID-19 vaccine is in Phase 3 trials and no efficacy data has been released so far. Trials for the vaccine are being tested in single dose and two-dose regimens.
The Johnson & Johnson COVID-19 vaccine is based on the tried and true vector delivery system method of using a weakened version of a related virus with elements of the new virus carried along. In this case the common cold virus adenovirus is used and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. This mechanism is an advantage to the mRNA COVID-19 vaccines because it can be stored at warmer temperatures.
In early clinical studies the Johnson & Johnson COVID-19 vaccine-induced local and systemic side-effects that are mild, to moderate. On Oct 13, the phase 3 trial was paused Johnson after a volunteer experienced unexplained illness after receiving the shot.
Johnson & Johnson is a participant in the United States Project Warp Speed initiative and was granted $1 billion on August 5th to produce the vaccine.
Recent Interesting Reports
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. ”
May 4, 2021 9:01 PM
“Company name: Hospira, Inc.
Brand name: Hospira, Inc.
Product recalled: Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial
Reason of the recall: Due to visible particulate
FDA Recall date: May 04, 2021
Recall details: Hospira, Inc., a Pfizer company, is voluntarily recallin... g lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.
Hospira’s assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction.
To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
The NDC, Lot Number, Expiration Date, and Configuration details for Sterile Water for Injection, USP, is indicated in the table below and a photo of the product can be found at the end of this press release. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020.
- Sterile Water for Injection, USP 100 mLbr Single-dose Glass Fliptop Vial. NDC: Vial: 0409-4887-25 | Carton: 0409-4887-99. Lot Number: DN9185. Expiration Date. 01 Apr 2023. Presentation: 100 mL, Single-dose Glass Fliptop Vial. Configuration: Tray of 25 vials.
Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers/ distributors/hospitals by letter to arrange for return of any recalled product.
Wholesalers, distributors or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. If you have further distributed the recalled product, to the wholesale or hospital level/institution, please notify any accounts or additional locations which may have received the recalled product from you. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Healthcare Professionals with questions regarding this recall can contact Pfizer using the information in the link below.
Check the full recall details on fda.gov
Source: FDA ”
April 28, 2021 5:52 PM
“Got the first dose of the Pfizer vaccine yesterday at Walgreens. Process was very smooth, no allergic reactions. Had some initial wooziness and lightheadedness 5 minutes after receiving the vaccine but may have just been anxiety.
Symptoms after 27 hours: sore arm, joint and muscle pain, fatigue.... Feeling warm/flushed but no fever. ”
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. ”
April 21, 2021 12:38 PM
“Blackcass.com is a total scam. My wife bought me what she thought was a mini electric chain saw. The site showed a sthil chain saw for $29.99 instead of $59.99. Not knowing the prices on tools she thought to surprise me. The next day I found her order in our computer and immediately contacted them a... nd tried to cancel it. They said it was too late as the order had already been processed. 10 weeks later we got a hand rose clipper instead. My wife had paid $37.99 for a clipper I got at Ace hardware before for $9.99 ”
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. ”
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 firstname.lastname@example.org 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 ”
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 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. ”
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 ”