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Updated: July 13, 2022 8:00 PM
Pfizer Propofol Injection Emulsion, USP - recalled due to Potential presence of visible particulate, USA
3 weeks ago
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial; lot DX9067, to the user level due to a visible particulate observed in a single vial during annual examination of retain... samples. The product lot was distributed nationwide to wholesalers/ hospitals/Department of Defense in the United States from June 10, 2020 through June 26, 2020.
The recalled product is:
- Propofol Injectable Emulsion, USP 100 mL Single Patient Use Glass Fliptop Vial, NDC: Vial: 0409-4699-54 Carton: 0409-4699-24, Lot Number: DX9067, Expiration Date Presentation: 01 MAY 2023, Configuration/Count: 1 g/100 mL, Single Patient Use Glass Fliptop Vial Case of 10 Units.
Risk Statement: Patients receiving the impacted product are at risk of experiencing life-threatening adverse clinical effects including but not limited to: blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur.
To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion, USP is a terminally sterilized (TS) product. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.
Wholesalers 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.
Company name: Hospira Inc, A Pfizer Company
Brand name: Hospira
Product recalled: Propofol Injection Emulsion, USP
Reason of the recall: Potential presence of visible particulate
FDA Recall date: July 13, 2022
Pfizer Accuretic™, quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets - recalled due to N-NitrosoQuinapril, USA
4 months ago
Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level.... To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.
Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets. 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.
These products are indicated for the treatment of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.
The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables in the link below and photos of the products can be found below. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022.
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
- quinapril and hydrochlorothiazide tablets, 20/25 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
Pfizer has notified direct consignees by letter to arrange for return of any recalled product.
Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.
If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.
Company name: Pfizer
Brand name: Accuretic, Greenstone Brand
Product recalled: Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets
Reason of the recall: Presence of a nitrosamine, N-nitroso-quinapril
FDA Recall date: March 22, 2022
Pfizer Vacccines and boosted still got Covid and have symptoms.
Covid Positive - Tightness in chest, headache, ear pressure, no fever, sneezing, exhaustion. | Symptoms: Headache, Fatigue
#coronaviruscovid19 #covid19omicronvariant #pfizer #covid19vaccine #pfizercovid19vaccine #roseville #california #unitedstates #headache #fatigue
7 months ago
I decided on Pfizer vs Moderna for my booster shot because of lower dose and less reported side effects. After the shot at 2pm, I got a sore arm after a few hours. Next day I had a fever around 100 and felt puny for the rest... of the day and went to bed. Next day I had no fever but felt below par in the morning and better as the day went by. Arm less sore 48 hours after shot but not back to normal just yet. | Symptoms: Fever, Soreness
#coronaviruscovid19 #pfizer #vaccine #covid19vaccine #pfizercovid19vaccine #nampa #idaho #unitedstates #fever #soreness
7 months ago
My whole family has it and I think so because with me it started out with a sore throat, then the next day I had a slight fever and cough along with congestion. Then the runny nose came with headaches across the eyebrow area and down the... nose some. I thought it was a head cold or maybe a upper respiratory type of thing. This past Monday I had to get a covid test because I was having a upper endoscopy done (very awful time for me with health issues) tuesday I got a call the procedure I can't have done because my covid test came back positive. On Tuesday I was actually getting ready to head out to have my booster covid shot. So that got put off as well. My whole family is experiencing all the same symptoms some more then the others. We are all fully vaccinated. My husband has the J&J vaccine, I had the Modena, and my kids both had Pfizer. | Symptoms: Fever, Runny Nose, Cough, Sore Throat, Congestion, Headache
#coronaviruscovid19 #covid19omicronvariant #johnsonjohnsoncovid19vaccine #modernacovid19vaccine #pfizercovid19vaccine #pfizer #moderna #johnsonjohnson #newyork #newyork #unitedstates #fever #runnynose #cough #sorethroat #congestion #headache
7 months ago
Received Pfizer booster shot at 1pm, only arm pain going to bed that night. Next day had pain in bones, skin, shivering, weakness 8 hrs and counting. | Symptoms: Weakness
#coronaviruscovid19 #pfizercovid19vaccine #covid19boostershot #covid19vaccine #pfizer #8635west3rdstreet #losangeles #california #unitedstates #weakness
My daughter and I had our Pfizer booster shot. We both had sore arms. We both had a mild upset stomach that only lasted a day. We're both happy that we were able to get our boosters. | Symptoms: Other
#featuredcovid19vaccinereports #pfizer #covid19vaccine #pfizercovid19vaccine #vaccine #covid19boostershot #pasadena #california #unitedstates
8 months ago
About 6 minutes after taking second pfizer dose, I began to sweat, blood pressure dropped, nausea set in and almost lost consciousness a couple of times. A nurse and a doctor stayed with me and offered some water. That didn't help ad after about an hour, I... was taken by ambulance to emergency room and treated with fluids and anti-nausea feeds. About 5-6 hours later I began to feel better and went home. | Symptoms: Nausea, Sweating
#coronaviruscovid19 #pfizer #covid19vaccine #pfizercovid19vaccine #whiteplains #maryland #unitedstates #er #nausea #sweating
8 months ago
Ayer nos pusimos el booster de Pfizer ,estamos con mucho dolor de brazo ,pero mi esposo desde ayer se siente muy canzado ,dolor de cuerpo y tiene mucho frío ,hoy se sentó a tomar una sopa y derrepente ya no me hablaba estaba blanco ,sus ojos desorbitados... y se desmayó ,después de un rato reaccionó y estaba mojado como si le hubiera bajado la presión pero no se acuerda de nada
Yesterday we put on the Pfizer booster, we have a lot of arm pain, but since yesterday my husband feels very cold, body aches and is very cold, today he sat down to have a soup and suddenly he no longer spoke to me, he was white, his eyes widened and he fainted, after a while he reacted and was wet as if his pressure had dropped but he does not remember anything | Symptoms: Dizziness, Chills, Body Ache
#covid19vaccine #pfizercovid19vaccine #pfizer #covid19boostershot #florida #unitedstates #dizziness #chills #bodyache
8 months ago
On Saturday November 20th, five family members got Pfizer booster vaccine. 24 Hours later one of them a 54 year old male had no symptoms. One male 26 got ver sick, vomiting, fever, muscle aches and a mouth gland very swollen, till now he has fever. A... 26 year old female also fever, vomiting, tight muscle chest and body aches, also swollen gland under vaccinated arm, she still feeling sick. A 33 year old also same symptoms as the female 26 year old. And me 52 years old only body and headache, and feeling better today. How long will this side effect last? I am so worried! | Symptoms: Fever, Vomiting, Headache, Body Ache, Swelling
#coronaviruscovid19 #pfizer #covid19vaccine #pfizercovid19vaccine #vaccine #sanmateo #california #unitedstates #fever #vomiting #headache #bodyache #swelling
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