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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 See Less

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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

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Priority mail packages bouncing up and down the east coast unnecessarily for days, 4 days later my package is further away from being delivered than when it started. Please fire the guy running this sh*t show. See Less

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Bronx. Wagon a package saying in transit since Saturday from teterboro  See Less

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USPS lost yet another package at their Teterboro distribution center, reporting "Processing Exception Delay" with no way to know if it will be resolved or not. See Less

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I was a premium TokyoTreat subscriber for 6 months, 35$/month, I got only 2 boxes, first when I subscribed, last one after I unsubscribed. Looks like real scam to me, they steal my money See Less

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Company name: Bryant Ranch Prepack
Brand name: Bryant Ranch Prepack
Product recalled: Methocarbamol 500mg
Reason of the recall: Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets.
FDA Recall date: October 19, 2021
Recall details: Burbank, CA, Bryant Ranch Prepack is voluntarily recalling... See More 1 lot of Methocarbamol 500mg, Tablets to the consumer level. The bottles labeled as Methocarbamol 500mg Tablets have been found to contain Methocarbamol 750mg Tablets.

Risk Statement: If a patient takes a 750mg Tablet of Methocarbamol instead of the prescribed 500mg Tablets, it potentially could result in Excessive Central Nervous System depression which may result in nausea, sedation, fainting, falls, seizure, coma, and death. Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

The product is used together with rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions and is packaged in a white round bottle with a red and white label, which reads Methocarbamol 500mg packaged in counts of 30 (NDC:7133517952), 60 (NDC: 7133517954), and 90 (NDC:7133517957) pills. The affected Methocarbamol 500mg lots include the following Lot Number 163935/ Exp. Date 10/22. The product can be identified by red and white label with a yellow border at the top and bottom of the label, top of the label reads “Packaged by Bryant Ranch Prepack”, labels are pictured below. The Methocarbamol 500mg was distributed Nationwide to multiple physician offices.

Bryant Ranch Prepack is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Consumers that have the bottles labeled as Methocarbamol 500mg Tablets which is being recalled should stop using immediately and return to place of purchase and/or contact their physician. Distributors/Physicians should stop distribution and contact Bryant Ranch Prepack to return the product immediately.

Check the full recall details on fda.gov

Source: FDA See Less

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The FSAI announced the recall of certain batches of Emergen-C Energy Release and Immunity Support Food Supplement due to the presence of the unauthorized pesticide ethylene oxide. Ethylene oxide is a pesticide that is not permitted for use in foods sold in the EU but is approved... See More for use by other countries outside the EU.

The recalled products are:
- Emergen-C Energy Release & Immunity Support Super Orange, Mega Pack 24 sachets, Lot # FUB03, Best before 01/24.
- Emergen-C Energy Release & Immunity Support Super Orange, Mega Pack 24 sachets, Lot # NT489, Best before 10/23.
- Emergen-C Energy Release & Immunity Support Super Orange, 8 sachets, Lot # GU393, Best before 10/23.

Although the consumption of the contaminated product does not pose an acute risk to health, there is an increased risk if there is continued consumption of contaminated food over a long period of time. Therefore, exposure to this substance needs to be minimised.

For more recall details check on FSAI website: fsai.ie

Source: FSAI See Less

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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 See Less

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I mailed out a Shutterfly book to my cousin in Fl, from where I live in NY on July 1st and the last known tracking of it was 4 days later in aTeterboro, NJ. It’s a bright orange package, you can’t miss! As of today Oct. 15th,... See More it’s still missing. In mid Sept. Shutterfly was nice enough to print a second book, which I had sent direct from Shutterfly to Fl. My cousin never got that book either. After contacting Shutterfly again, they were kind enough to send out a 3rd book, which she finally got. For the first package, I sent out, I put in a missing claim with USPS and continue to get emails saying they are still working on finding my missing package. What a joke. See Less

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