SYMJEPI Injection Pre-Filled Single-Dose Syringes - recalled due to potential clogging of the needle, USA

2 years ago •source www.fda.gov

Recall notice

United States

Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes SYMJEPI in the United States, under license from Adamis, the NDA holder.

USWM will handle the entire recall process for Adamis, with Adamis oversight. SYMJEPI is manufactured and tested for Adamis by Catalent Belgium S.A. Risk Statement: If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date.

However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall. The recall encompasses all of the following batches, within expiry:

+ SYMJEPI (epinephrine) Injection.
-- Strength: 0.15 mg/0.3 mL. NDC: 78670-131-02. Lot: 21101Y. Expiration: 11/30/2022
-- Strength: 0.3 mg/0.3 mL. NDC: 78670-130-02. Lot | Expiration: 21041W | 8/31/2022. 21081W | 11/30/2022. 21102W | 2/28/2023

SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

The products are packaged in 2-count Pre-Filled Single-Dose Syringes per carton and were distributed nationwide in the USA and directly to customers and/or medical facilities. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons below.

Company name: Adamis Pharmaceuticals Corporation
Brand name: Adamis Pharmaceuticals Corporation
Product recalled: SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes
Reason of the recall: Potential clogging of the needle preventing the dispensing of epinephrine
FDA Recall date: March 22, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection

#drugs #recall #us #sub

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Florida, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia markets. Cargill discovered the issue after receiving a report of young meat birds diagnosed with rickets.

Lack of Vitamin D in meat bird diets can lead to mineral deficiencies and bone issues, including rickets in growing birds. Symptoms include lameness and rubbery bones.

The recalled product is:
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The lot code and manufacture date can be found on the bottom right-hand side of the label.

Consumers and other end users who have any of the affected lots in their possession should return remaining product to their local dealer or retailer for a replacement or full refund.

In case your birds 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.

Company name: Cargill
Brand name: Nutrena Country Feeds
Product recalled: Meat bird 22% Crumble (RV)
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Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cargill-conducts-voluntary-recall-nutrenar-country-feedsr-meatbird-22-crumble-due-non-inclusion
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ADM Animal Nutrition, a division of ADM (NYSE: ADM), is expanding the recall announced on March, 30, 2024, to include the following additional products due to elevated levels of magnesium, sodium, calcium and/or phosphorus: Pen Pals® Chicken Starter-Grower (Product Nos.70009AAA46 and 70009AAA44); Pen Pals Egg Maker Complete … See More
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Brand name: Pen Pals, MaxLean, ShowTec, MoorMan's
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Global Mix, Inc. of New York, is recalling tejocote products to include the following brands: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra. The recalled products are labeled as tejocote root but are toxic yellow oleander. The recalled products were distributed in the following states: AL, AK, … See More
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Recalled Products include the following bearing below information. Product codes and expiration dates can be found on the bottom of the packaging.

Product Name: Eva Nutrition MexicanTejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Science of Alpha Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: NWL Nutra Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Niwali Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025

Per the safety alert update on 3/12/24, "The FDA continues to receive adverse event reports related to the products identified in this Safety Alert."

The recall was the result of a routine sampling program by the company which revealed that the finished products contained the yellow oleander. The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem. Further the company is conducting comprehensive quality control and monitoring process.

Customers who have purchased these products should stop using them immediately and return them to the point of purchase for a full refund.

Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

If you are experiencing symptoms after eating 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: Global Mix, Inc.
Brand name: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra
Product recalled: Tejocote Dietary Supplements
Reason of the recall: Product contains toxic yellow oleander.
FDA Recall date: April 10, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-mix-inc-recalls-tejocote-products-because-possible-health-risk
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Company name: Medline Industries, LP
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If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: www.cpsc.gov/Recalls/2024/Procter-Gamble-Recalls-8-2-Million-Defective-Bags-of-Tide-Gain-Ace-and-Ariel-Laundry-Detergent-Packets-Distributed-in-US-Due-to-Risk-of-Serious-Injury
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Recent Interesting Reports

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N

I ordered it from Temu online, Singleton NSW, Australia

3 weeks ago •reported by user-npyn6421

I ordered a laptop so I could start Tafe course but nothing has come so I would like my money back
And This is some custom learning Center, the laptop I ordered off, you're still at a couple weeks ago. Res. Thank you.
I bought a laptop from the Temu website

#onlineshopping #scam #delivery #onlinescam #singleton #newsouthwales #au

F
I received a package that I didn’t order item is called subgenix don’t know what it is. P.O. Box 5708.

#unorderedpackage #delivery #tampa #florida #us

J

user-jfdgt122

I received something similar, different containers, same address and product name.

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
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I received a package today, March 25, 2024 that I did not order. The package contains 2 bars of orange soap. There's no lable or anything attached. I looked up the address from where it was shipped from in California. It's a warehouse called Cambria that is … See More
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N

user-nnwmq264

Am comandat astazi 4 bluze si mi-au venit bluze mucegaite si cel mai probabil SH, ati reusti sa dati retur produselor si sa va recuperati banii?

Y

A package I did not order, Tampa, FL, USA

3 weeks ago •reported by user-yzkcv884

Received a package from Fullfillment House in Tampa. It’s a container of cream that say Subgenix. Extra strength. Not sure what it is or why I received it. No papers in the packaging

#unorderedpackage #delivery #tampa #florida #us #cream

R

user-rffp5242

What is this for I didn't order it any information would be great.

Global Mix, Inc. of New York, is recalling tejocote products to include the following brands: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra. The recalled products are labeled as tejocote root but are toxic yellow oleander. The recalled products were distributed in the following states: AL, AK, … See More
CA, CO, CT, DE, FL, GA, HI, ID, IL, IA, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NM, NC, NY, NJ, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, and WY through website. The recalled products were also sold via the below websites via courier direct delivery and mail order. Etsy, amazon, eva-nutrition, tejocotemexican, niwali, scienceofalpha. The recalling firm has not received any reported of illness.

Recalled Products include the following bearing below information. Product codes and expiration dates can be found on the bottom of the packaging.

Product Name: Eva Nutrition MexicanTejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Science of Alpha Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: NWL Nutra Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Niwali Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025

Per the safety alert update on 3/12/24, "The FDA continues to receive adverse event reports related to the products identified in this Safety Alert."

The recall was the result of a routine sampling program by the company which revealed that the finished products contained the yellow oleander. The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem. Further the company is conducting comprehensive quality control and monitoring process.

Customers who have purchased these products should stop using them immediately and return them to the point of purchase for a full refund.

Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

If you are experiencing symptoms after eating 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: Global Mix, Inc.
Brand name: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra
Product recalled: Tejocote Dietary Supplements
Reason of the recall: Product contains toxic yellow oleander.
FDA Recall date: April 10, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-mix-inc-recalls-tejocote-products-because-possible-health-risk
See Less

#recall #us

P

I did not order this, Florida, USA

1 week ago •reported by user-pnjp2536

I received this product I do not know what it is. I never ordered this I’m afraid to open it up. I don’t do stuff like this so I don’t even know why you sent it to me. Can someone please help me I will have to cancel all my credit cards because it’s too much scam out there.

#unorderedpackage #delivery #florida #us

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