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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Kappler, Inc., 55 Grimes Dr, Guntersville, AL 35976, United States

Total all time reports:  1
Latest report: April 20, 2020 12:00 PM
Coronavirus: An employee had tested positive in Kappler Inc., Kappler, Inc., 55 Grimes Dr, Guntersville, AL 35976, United States

Coronavirus: An employee had tested positive in Kappler Inc.

April 20, 2020 12:00 PM

“A protective clothing manufacturer in Guntersville reported an employee tested positive for COVID-19 on April 16th.


Source: whnt.com See Less
Reported By SafelyHQ.com User

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“Company name: Ferring Pharmaceuticals US
Brand name: Ferring, Amring, CSL Behring
Product recalled: DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL
Reason of the recall: Superpotency
FDA Recall date: August 05, 2020
Recall details: ... See MoreFerring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing. The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could eventually lead to seizure, coma, and death.

To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed. DDAVP® Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Desmopressin Acetate Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Stimate® Nasal Spray is indicated for the treatment of patients with hemophilia A with Factor VIll coagulant activity levels greater than 5%.

Stimate® Nasal Spray is indicated for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

Ferring US is notifying its distributors and wholesale customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter. You can see the affected product name, including the batch numbers and expiration dates, in the link below.

Distributors/wholesalers with questions regarding the recall should call Stericycle at 1-888-228-5053. 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.

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Check the full recall details on fda.gov

Source: FDA
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“Company name: Chengdu Ai Qin E-commerce Co., Ltd
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FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiate ... See Mored a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. The company has received no complaints to date.

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- TTDeye. Devil Red. Lot code: B16112201

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.com between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Check the full recall details on fda.gov

Source: FDA
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“Company name: Albek de Mexico S.A. de C.V
Brand name: Nuuxsan, Modesa, Assured, more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 31, 2020
Recall details: Albek de Mexico S.A. de C.V is voluntarily recalling all lots and all brands of hand sa ... See Morenitizer currently in US distribution to the consumer level. This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product was presented for import into the United States. Risk Statement: Substantial methanol exposure could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) or death. Persons using methanol-based products on their hands may be at risk. Young children who accidently ingest them and adolescents and adults who drink such products are most at risk for methanol poisoning. To date, there have been no reports of serious adverse events related to the products in the scope of this recall. The products are labeled for use as a hand sanitizer (or “antiseptic”) and are packaged for several nationwide distributors in a variety of formats as you can see in the link below.

The products were distributed nationwide in the United States beginning on November, 15 2019.

Albek is partnering with its distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled products. Consumers, distributors, and retailers that have product which is being recalled should stop use or distribution and return to place of purchase.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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July 24, 2020 12:00 PM

“Company name: Real Clean Distribuciones SA de CV
Brand name: Born Basic, Scent Theory and more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared methanol
FDA Recall date: July 24, 2020
Recall details: La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntari ... See Morely recalling all lots it manufactured within expiry of the following brand names of hand sanitizers:
- Born Basic ANTI-BAC HAND SANITIZER
- Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer
- Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer
- Lux Eoi Hand Sanitizing Gel to the consumer level.

The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Real Clean Distribuciones SA de CV has not received reports of adverse events related to this recall.

RECALLED PRODUCTS These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. Real Clean Distribuciones SA de CV manufacturers product for four brands included in this recall. Scent Theory and Born Basic hand sanitizer products are produced by several different manufacturers, in several different countries, and only those lots manufactured by Real Clean in Mexico are subject to the recall. The recalled products include the following lots:

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Scent Theory Keep Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Keep it Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 34oz
Lot Numbers: 0133420, 0233420, 0333420, 0433420, 0533420, 0633420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 9.5oz
Lot Numbers: 0133720, 0233720

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Lux Eoi Hand Sanitizing Gel
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133920, 0233920, 0333920

Real Clean Distribuciones SA de CV is notifying its distributors by recall letter and consumers via this press release. Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/selling Hand Sanitizer and return it to the place of purchase; because the affected products are considered hazardous materials, do not destroy the affected products.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User