Braun Medical Inc Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container - recalled due to Out-of-Specification Results, B. Braun Medical Inc, 824 12th Avenue, Bethlehem, Pennsylvania 18018, USA

3 years ago

Braun Medical Inc Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container - recalled due to Out-of-Specification Results, B. Braun Medical Inc, 824 12th Avenue, Bethlehem, Pennsylvania 18018, USA

824 12th Avenue, Bethlehem, 18018 Pennsylvania, United States

Company name: Braun Medical Inc
Brand name: B. Braun
Product recalled: Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container
Reason of the recall: Out-of-Specification Results for High Molecular Weight Polymers
FDA Recall date: April 20, 2020
Recall details: Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval. Elevated levels of High Molecular Weight Polymers have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels.

To date there have been no complaints or reports of adverse reactions associated with this product lot. Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Lower respiratory tract infections; skin and skin-structure infections; bacterial septicemia; bone and joint infections; gynecologic infections; intra-abdominal infections; and central nervous system infections.

Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container containing approximately 50 mL of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime. Ceftazidime for Injection USP and Dextrose Injection USP is packaged in 24 DUPLEX® Containers per case. The affected recalled product includes the following lot number and expiration date:

- NDC: 0264-3145-11. Ref: 3145-11. Dose/Volume: 2 g per 50 mL. Impacted batch: H8J812. Exp. Date: 31 Jul 2020.

Product was distributed Nationwide within the United States to domestic distributors. Pictures of the product and product labeling follow this press release.

B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-one-1-lot-ceftazidime-injection-usp-and

Source: FDA

#drugs #82412thavenue #bethlehem #pennsylvania #us

Braun Medical Inc Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container - recalled due to Out-of-Specification Results photo #1
185

Related Reports

Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance, USA

1 week ago •source www.fda.gov

Recall notice

Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has been found to be non-compliant with current good … See More
manufacturing practice (cGMP) requirements. To date, Honeywell Safety Products USA, Inc. has not received any reports of adverse events related to this recall.

The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Region: USA. Quantity: 6,954.

- Fendall 2000 Non-Sterile Eyewash Cartridge. Manufacturer’s Product Number/ Catalog Number: 32-002050-0000. Manufacturing Dates: 11-Oct- 2021 through 21-Jun-2023. Expiration Date: 11-Oct-2023 through 21-Jun-2025. Canada. Quantity: 3,651

Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it. Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone.

Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.

Company name: Honeywell Safety Products USA
Brand name: Fendall 2000
Product recalled: Non-Sterile Eyewash Cartridge
Reason of the recall: Non-compliance with current good manufacturing practice (cGMP) requirements.
FDA Recall date: April 05, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/honeywell-safety-products-usa-inc-issues-voluntary-worldwide-recall-honeywell-fendall-2000-non
See Less

#drugs #recall #us

Honeywell Non-Sterile Eyewash Cartridge - recalled due to Non-compliance photo #1
303

AvKARE, LLC Atovaquone Oral Suspension - recalled due to potential Bacillus cereus contamination, USA

2 weeks ago •source www.fda.gov

Recall notice

AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. Atovaquone Oral Suspension, USP was distributed between 03/18/2024 through 03/21/2024 … See More
Nationwide to Wholesalers. To date, AvKARE has not received any reports of adverse events related to this recall.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025.

AvKARE, LLC is notifying its distributors and wholesale customers by mailings and email communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP. Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC. Consumers that have product which is being recalled should stop using the product and return it to place of purchase.

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

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: AvKARE, LLC
Brand name: AVpak
Product recalled: Atovaquone Oral Suspension, USP 750mg/5mL
Reason of the recall: Potential Bacillus cereus contamination
FDA Recall date: April 01, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due
See Less

#drugs #us

AvKARE, LLC Atovaquone Oral Suspension - recalled due to potential Bacillus cereus contamination photo #1
303

AuroMedics Pharma Methocarbamol Injection - recalled due to Particulate Matter presence, USA

2 weeks ago •source www.fda.gov

Recall notice

Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating … See More
inside of the vial.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024.

The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10) (See enclosed vial label). The product label is as shown in the image below.

Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product lot, 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.

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.

If you are experiencing any harm after using this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Eugia US LLC
Brand name: Eugia US LLC
Product recalled: Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)
Reason of the recall: Device & Drug Safety – Presence of Particulate Matter
FDA Recall date: March 28, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection
See Less

#drugs #recall #us

AuroMedics Pharma Methocarbamol Injection - recalled due to Particulate Matter presence photo #1
304

Amneal Vancomycin Hydrochloride for Oral Solution - recalled due to super poteny risk, USA

2 weeks ago •source www.fda.gov

Recall notice

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: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution
See Less

#drugs #recall #us

Amneal Vancomycin Hydrochloride for Oral Solution - recalled due to super poteny risk photo #1
303

Pyramid Wholesale Dietary supplements for sexual enhancement - recalled due to Undeclared Sildenafil and/or Tadalafil, California, USA

3 weeks ago •source www.fda.gov

Recall notice

Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). There have been no reports of injury or illness, to date. They were sold in bulk to … See More
other distributors and retailers in California and out of state.

These products have the potential to cause severe adverse health effects due to misuse, overuse, interaction with other medications, underlying health conditions, and overall lack of oversight or consultation with medical professionals.

The products were distributed under 11 different brand names and varied in product form and size. A full list is available in the link below. Consumers should immediately discontinue use of the product.

Company name: Pyramid Wholesale
Brand name: Various
Product recalled: Dietary supplements for sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: March 20, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement
See Less

#supplement #drugs #california #us

Dietary supplements for sexual enhancement - recalled due to undeclared drugs photo #1
288
A

Boil Water Advisory, E Bethlehem Blvd, Bethlehem, WV 26003, USA

1 year ago

A water line break on East Bethlehem Boulevard has forced officials to shut the water off from the water tower. Anyone who has lost water service or has had low pressure is under a 48-hour boil order for consumption.

Source: twitter.com/WTOV9/status/1547942694671880200
Published: 2022-07-15 See Less

#boilwateradvisory #eastbethlehemboulevard #bethlehem #westvirginia #us

34

Recent Interesting Reports

R

Ring Scam, Yucca Avenue, Lancaster, CA, USA

2 weeks ago •reported by user-rzyzb777

Received package in the mail. Contained a ring in a box that I never ordered.
Company on package says YOSHI DEALS

#unorderedpackage #delivery #44211yuccaavenue #lancaster #california #us

Ring Scam photo #1
110
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user-rgwwd937

Same thing happened to me

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user-qnpcy626

I received a package from Yoshi Deals Lancaster, CA with a ring that I never ordered. I never heard of Yoshi Deals.

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Me too!!

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user-fxyj5852

It's probably April fools prank

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user-fxyj5852

Don't scan the QR code

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user-mgry4339

Me toook

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user-fndkn618

I got one too

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user-thfq4993

We received one as well.

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user-hpcq8434

What do we do about it?

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user-jftf8382

I just got one as well

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user-qnpcy626

I received a package with a ring today from Yoshi Deals/Lancaster, CA. Never heard of Yoshi Deals & never ordered a mosinite ring.

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user-hzzh9419

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user-vxxw1668

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user-qxnq4424

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user-kzrv5826

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Not acceptable product. Inferior. Not as advertised!, Summit Ave, Union City, NJ 07087, USA

3 weeks ago •reported by user-twjrc443

I ordered two bras that I saw advertised and I received two cheap cheap cheap poorly made inferior having nothing to do with the two they advertised and they ripped me off about $40

#onlineshopping #scam #onlinescam #delivery #2207summitavenue #unioncity #newjersey #us

Not acceptable product. Inferior. Not as advertised! photo #1
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Pyramid Wholesale Dietary supplements for sexual enhancement - recalled due to Undeclared Sildenafil and/or Tadalafil, California, USA

3 weeks ago •source www.fda.gov

Recall notice

Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). There have been no reports of injury or illness, to date. They were sold in bulk to … See More
other distributors and retailers in California and out of state.

These products have the potential to cause severe adverse health effects due to misuse, overuse, interaction with other medications, underlying health conditions, and overall lack of oversight or consultation with medical professionals.

The products were distributed under 11 different brand names and varied in product form and size. A full list is available in the link below. Consumers should immediately discontinue use of the product.

Company name: Pyramid Wholesale
Brand name: Various
Product recalled: Dietary supplements for sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: March 20, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement
See Less

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Dietary supplements for sexual enhancement - recalled due to undeclared drugs photo #1
288
C

Did not order pkg rcd, MN, USA

2 weeks ago •reported by user-chrr4191

I did receive a pkg I did not order
Return address: shipping center
609 cattle chute court
Celina tx 75009
A cheap looking gold plated watch

#unorderedpackage #delivery #minnesota #us

Did not order pkg rcd photo #1
77
Z

user-zfjpb589

i also received a gold plated cheap watch with fake diamonds around it from shipping center, 609 cattle chute ct, celina, texas 75009 just today and I'm in hawaii.

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