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Pfizer first dose, San Francisco, CA, USA

2 years ago

San Francisco, California, United States

on 3/22 I had the first dose administered at the local Walgreens and it was quick and easy....I barely felt it happen and had slight soreness in the shot area on my left shoulder that day and the next but no other symptoms. Second dose is scheduled for 4/19. | Symptoms: Soreness

632


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Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples. The product lot... See More was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020. To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.

Risk Statement: Patients receiving the impacted product have a remote probability of experiencing potential adverse events, such as 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.

Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion 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 Glass Fliptop Vial. The NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion are indicated below.

Product: Configuration/Count Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial
NDC: Vial: 0409-4699-54 Tray: 0409-4699-24
Lot Number: EA7470
Expiration Date: 01 JUNE 2023
Presentation: 1g/100 mL, Single Patient Use Glass Fliptop Vial
Configuration/Count: Tray of 10 Units

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers or hospitals with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution and quarantine immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. 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: August 22, 2022

Source: fda.gov
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303


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... See More 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

Source: fda.gov
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303


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.... See More 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

Source: fda.gov
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303


Nearly 8,000 Pacific Gas and Electric customers in San Francisco were without power on March 25th, Monday morning during a series of power outages affecting the Presidio and other neighborhoods in the northern part of the city. PG&E indicated that main outage began just before 8 a.m.... See More and was affecting the Presidio area as well as areas around Fort Mason, Russian Hill, Pacific Heights, and the Inner Richmond neighborhoods.

Outage link: pgealerts.alerts.pge.com
Source: msn.com
Published: 2024-03-26
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632


An estimated 8,000 customers were affected by a power outage Tuesday morning, Mar 26 in San Francisco. The outage started at 7:56 a.m. and left about 7,860 San Francisco customers without power. At 11:16 a.m. a total of approximately 1,779 customers were still affected. The preliminary cause... See More is a damaged underground cable. The outage mostly affected the city's northern neighborhoods, stretching across the Presidio through Cow Hollow, Fort Mason, and Russian Hill and south into parts of Pacific Heights along Laguna Street. According to PG&E the preliminary estimated time of restoration of 3:30 p.m.'

Outage link: pgealerts.alerts.pge.com
Source: sfstandard.com
Published: 2024-03-26
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According to the PG&E outage map, a power outage affected 3,665 customers in San Francisco on Tuesday afternoon, Mar 19. The affected area is near Fulton Street, Golden Gate Park, Lincoln Park Los Lobos, and surrounding areas. The outage started at 3:05 p.m. PST. The estimated time... See More for restoration is 9:45 p.m. PST. PG&E is investigating the cause of the outage. Crews are working to restore power to the area.

Outage link: pgealerts.alerts.pge.com
Source: pge.com
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According to PG&E’s outage map, a power outage affected 4,301 customers in the Japantown area on Thursday morning, Mar 7. The outage started at 7:14 a.m. PST The estimated time for restoration is 10:45 a.m. PST. PG&E is investigating the cause of the outage. Crews are working... See More to restore power to the area.

Outage link: pgealerts.alerts.pge.com
Source: pge.com
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Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can... See More result in an over-potent dosing regimen. The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613005A, NDC No.: 69238-2261-7.
- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Reason of the recall: Super potent due to bottles being overfilled
FDA Recall date: March 27, 2024

Source: fda.gov
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