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Stonefire Grill, Brookhurst Street, Fountain Valley, CA, USA

Total all time reports:  1
Latest report: July 5, 2020 12:00 PM
#coronaviruscovid19 #18727brookhurststreet #fountainvalley #california #unitedstates
DA

Employee test positive for Covid-19

1 year ago

A few staff members at Stonefire Grill in Fountain Valley have tested positive for COVID-19

Source: ocregister.com See Less
7.0K


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I recently returned to this gym for the first time since it was locked down in March 2020. I’ve been going for 3 days a week for two weeks straight and not once was I asked for proof of my vaccination status. There seem to be no... See More enforcement of COVID protocols including requiring proof of vaccination, distancing, or consistent cleaning. See Less
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Recent Interesting Reports

Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility... See More assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.

Intravenous administration of a non-sterile drug could result in serious infections ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides, and wound infection which may be life-threatening. The possibility of a breach in sterility assurance in distributed products, while not confirmed, cannot be eliminated. No batches of the product have been identified as containing microorganisms. To date, IntegraDose Compounding Services has not received reports of any adverse events associated with this issue for these lots.

- Cefazolin 2 gram in 20 mL syringe for injection. (See link below for a detailed list of Lots)
- Cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection. (See link below for a detailed list of Lots)

Cefazolin is an antibiotic and the products are packaged in zip-locking bags containing ten units. The lots were distributed nationwide in the USA to hospitals from 8/12/21 to 9/15/21. IntegraDose Compounding Services has initiated an investigation to determine the root cause and corrective and preventative actions.

IntegraDose Compounding Services has notified its direct customers via a recall letter and is arranging for the impacted product to be returned. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately.

Consumers with questions regarding this recall can contact IntegraDose Compounding Services by phone at (612-672-5216) on Monday - Friday, 8:00 AM – 4:00 PM CDT.

Company name: IntegraDose Compounding Services, LLC
Brand name: IntegraDose Compounding Services, LLC
Product recalled: Cefazolin
Reason of the recall: Lack of sterility assurance.
FDA Recall date: September 21, 2021

Check the full recall details on fda.gov

Source: FDA
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Shipment was supposed to arrive Friday.  Now I received the following message : Your shipment has potentially been delayed due to emergency or other conditions at 6:46 pm on October 17, 2021. | Symptoms: Other See Less
5.1K


GR
Grinsler
Same here. Mine arrived at Teterboro 10/14 @ 3:35 pm. 10/17 update says "Processing Exception, Other Delay Your shipment has potentially been delayed due to emergency or other conditions at 6:50 pm on October 17, 2021."
Reply 2 days ago
MI
Mitch
Same very important documents are there What the hell is going on
Reply 11 hours ago
Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary... See More recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. The needles were recalled due to complaints of rust on the products. Use of affected products could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death.

The U.S. Food and Drug Administration (FDA) has not yet classified the recall. Products affected by this recall are:
- Transseptal Needle, INTENDED USE: Intended for transseptal left heart access in both diagnostic and interventional procedures, RPN: TSNC-18-71.0 GPN: G02364 and RPN: TSNC-19-56.0 GPN: G02365, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
- Transseptal Needle with Catheter, INTENDED USE: Intended to facilitate transseptal entry into the left atrium, RPN: TSN-17-75.0-ENDRYS, GPN: G19261, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021

Transseptal Needles, including Transseptal Needles with Catheters, were found to have rust internally, externally, or both. To date, Cook Medical has received no reports of injury or illness related to this recall. Cook has received four complaints where the presence of rust was identified prior to patient contact. However, please be advised that the presence of rust may go undetected by the user. The FDA and other regulatory agencies around the world have been notified of this action.

Potential adverse events: If an affected product is used, potential negative outcomes include increased procedural time (to obtain a replacement device) and inflammatory reactions ranging from local or self-limited reactions to systemic reactions requiring medical intervention. Systemic reactions could potentially lead to permanent impairment or death.

Check the full recall details on fda.gov

Source: FDA
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Company name: Eli Lilly and Company
Brand name: Lilly
Product recalled: Glucagon Emergency Kit
Reason of the recall: Loss of potency
FDA Recall date: September 26, 2021
Recall details: Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit... See More for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form.

The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.

Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. The product is packaged in a kit containing 1mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. The affected Glucagon Emergency Kit lot is D239382D and the expiration date is April 2022 (label expiry date: 04 2022). The lot number can be found on the label of the kit as well as the vial (refer to the photos provided below – Appendix A). The lot was distributed nationwide to wholesalers and retailers.

Wholesalers and Distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately.

Instructions for Wholesalers and Pharmacists: If you have distributed the recalled product, please notify any accounts or additional locations which may have received product from the recalled lot from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

Instructions for Consumers: Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center at 1-800-545-5979 for return and replacement instructions for the product (hours of operation are Monday- Friday, 9AM – 7PM EST) and should contact their health care provider for guidance. 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. APPENDIX A The Lot Number is found on the kit and vial labels as can be seen in the example label below. 

Check the full recall details on fda.gov

Source: FDA
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Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV, or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. To date, Bayer... See More has no known reports of adverse events related to this recall.

Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow, and blood disorders that can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally.

The affected Lotrimin® and Tinactin® spray products are over-the-counter antifungal products, sold individually or in combo packs.

The impacted products are:
- Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
- Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
- Lotrimin® AF Athlete's Foot Liquid Spray
- Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
- Tinactin® Jock Itch (JI) Powder Spray
- Tinactin® Athlete’s Foot Deodorant Powder Spray
- Tinactin® Athlete’s Foot Powder Spray
- Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available at the link below. There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada, and Mexico through a variety of retail channels.

Bayer is also notifying its distributors and retailers by letter and is arranging for returns of all voluntarily recalled products. Consumers who have the products that are being recalled should stop using them.

Check the full recall details on fda.gov

Company name: Bayer U.S. LLC
Brand name: Lotrimin® AF and Tinactin®
Product recalled: Over the Counter (OTC) antifungal spray products
Reason of the recall: Presence of benzene
FDA Recall date: October 01, 2021

Source: FDA
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Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level.  Coppertone has identified the presence of benzene in these lots of products Twelve lots of... See More Coppertone spray products are impacted by this voluntary recall, specifically:

- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . Lot: TN0083J UPC: 72140028817. Manufacturing Date: 44470.
- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . TN0083J: TN0083K 72140028817: 72140028817. Manufacturing Date: 44501.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN0083K: TN00854 72140028817: 72140028824. Manufacturing Date: 44531.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN00854: TN00855 72140028824: 72140028824. Manufacturing Date: 1/14/2021.
- Product Description: CT SPORT MIN SPF50 SPRAY 5OZ 12S . TN00855: TN008KU 72140028824: 72140028701. Manufacturing Date: 3/15/2021.
- Product Description: CT SPORT MIN SPF50 SPRAY 5OZ 12S . TN008KU: TN008KV 72140028701: 72140028701. Manufacturing Date: 3/16/2021.
- Product Description: CT P&S SPF50 SPRAY 5OZ 12S . TN008KV: TN00BR2 72140028701: 72140028800. Manufacturing Date: 3/31/2021.
- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . TN00BR2: TN009GH 72140028800: 72140028817. Manufacturing Date: 3/31/2021.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN009GH: TN00857 72140028817: 72140028824. Manufacturing Date: 44351.
- Product Description: CT SPORT SPRAY SPF50 1.6OZ 24S . TN00857: TN00BU3 72140028824: 41100005069. Manufacturing Date: 44352.
- Product Description: CT P&S SPF50 SPRAY 5OZ 12S . TN00BU3: TN00CJ4 41100005069: 72140028800. Manufacturing Date: 6/15/2021.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN00CJ4: TN00CJV 72140028800: 72140028824. Manufacturing Date: 6/15/2021.

Benzene is classified as a human carcinogen. Exposure to benzene can occur through inhalation, oral, and skin and it could, depending on the level and extent of exposure, result in an increased risk of cancers including leukemia, and blood cancer of the bone marrow and other blood disorders which can be life-threatening.

Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies.

Out of an abundance of caution, we are recalling certain lots of these specific aerosol sunscreen spray products. To date, Coppertone has not received any reports of adverse events related to this recall.

The voluntarily recalled sunscreen spray products are packaged in aerosol cans. The products were distributed nationally in the United States through various retailers. Consumers should stop using these specific Coppertone aerosol sunscreen spray products and dispose of them appropriately.

Coppertone is also notifying its retailers by letter and is arranging for returns of all voluntarily recalled lots of sunscreen spray products. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these aerosol sunscreen spray products.

The FDA and other medical authorities recognize the public health benefits of sunscreens and strongly advise the use of sunscreen along with other protective measures from the sun.

Company name: Coppertone, owned by Beiersdorf
Brand name: Coppertone
Product recalled: Coppertone aerosol sunscreen spray products
Reason of the recall: Presence of benzene
FDA Recall date: September 30, 2021

Check the full recall details on fda.gov

Source: FDA
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This is the 2nd package that just arrives at teterboro and just stops moving what’s the point of charging for next day air if you can’t get it done .. worse thing about this is that’s it’s anxiety medication i desperately need See Less
5.1K


HA
Hate USPS
I wonder if we could all group together and file a class action lawsuit. I saw another post here with two tracking #s stuck from October 1st and Sept 28th that haven’t moved yet.
Reply 5 days ago
October 11, 2021 – Tuffy's Pet Foods is issuing a voluntary recall of approximately 1,600 cases of Pure Vita Salmon Entree Dog Food in a Tetrapak carton following notification from the product manufacturer of potentially elevated levels of Vitamin D. No illnesses or injuries have been reported... See More from consumers to date.

Consuming elevated levels of vitamin D in dog food can cause adverse reactions in dogs of all sizes, including symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. When ingested at excessive levels, vitamin D can lead to serious health issues in dogs including renal dysfunction. While no reports of illness or injury have been reported from consumers to date, Tuffy’s is acting out of an abundance of caution and is removing the specific lots of product listed below from distribution.

Consumers should stop feeding the product listed below to their pets immediately. Tuffy’s recommends consumers whose dogs have consumed the potentially affected product and are exhibiting any of the above-mentioned symptoms contact their veterinarian.

- Pure Vita Salmon Entrée Dog Food TetraPak (12.5 oz. per carton). UPC: 0 73893 96202 1. Lot numbers: 0629101N1 /
0901101N1. Best By dates: 29 Jun 2023 / 1 Sep 2023.

The recalled product was distributed exclusively within the United States to distributors and retail stores.  The recalled product is limited to Pure Vita Salmon Entrée Dog Food in a Tetrapak carton, bearing UPC Code "0 73893 96202 1" (found on side of the carton).  Products included in the recall are identified by the "Best by Dates" and “Lot Numbers” (found on the top of the carton) as listed above. No other Pure Vita dog or cat foods, or treats are affected by this announcement.

Consumers who purchased the Pure Vita Salmon Entrée dog food product subject to this voluntary recall (as identified above) are urged to return the product to their retailer for a full refund.

For consumer information or questions regarding this voluntary recall, please contact Tuffy’s Pet Foods, Inc. at (800) 525-9155 from Monday-Friday, 8:00am-5:00pm Central Time

Company name: Tuffy’s Pet Foods, Inc.
Brand name: Nutri Source
Product recalled: Pure Vita Salmon Entrée Dog Food
Reason of the recall: Elevated Levels of Vitamin D
FDA Recall date: October 12, 2021

Check the full recall details on fda.gov

Source: FDA
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Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg
Reason of the recall: API batches above the specification limit for the impurity, N-nitrosoirbesartan
FDA Recall date: October 14, 2021
Recall details: Baltimore, Maryland, October 14, 2021:... See More Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.

Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.

Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021. Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide. Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021. The recalled lots are included in the link below.

Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Irbesartan and hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021. The recalled lots are included in the link below.

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking, Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg that are being recalled should discontinue distribution of the recalled product lots immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 769-3988 / (855) 769-3989.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.

Check the full recall details on fda.gov

Source: FDA
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