Month: July 2020

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol
Company Name:
4e Brands North America
Brand Name:
Assured, Blumen, Modesa
Product Description:
Hand Sanitizer

Company Announcement

San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer brands to the consumer level. These 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. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared Methanol subpotency ethyl alcohol
Company Name:
Resource Recovery & Trading, LLC
Brand Name:
Resource Recover & Trading, LLC
Product Description:
Hand Sanitizer

Company Announcement

RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling all the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level. The products are being recalled due to the potential presence of undeclared methanol (wood alcohol) and subpotency ethyl alcohol.

Risk Statement: The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreased bactericidal and virucidal activity. Adverse health consequences can be related to increased infections. In addition substantial, undeclared methanol exposure, which has inferior antiseptic properties compared to ethanol, can 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 accidently 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, RESOURCE RECOVERY & TRADING LLC has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared Milk
Company Name:
Wellements LLC
Brand Name:
Wellements
Product Description:
Iron Drops liquid Dietary Supplement and Iron Drops Sample liquid Dietary Supplement

Company Announcement

Wellements LLC of Scottsdale, Arizona, is issuing a voluntary recall of two lots of its 1oz/30ml bottle of Iron Drops (UPC 729609000098) liquid Dietary Supplement and the sample version being Iron Drops Sample liquid Dietary Supplement because they may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergens run the risk of serious allergic reaction if they consume these products.

The recalled Iron Drops were distributed from 5.1.2019 to 7.22.2020 nationwide through select retail stores, Amazon.com and Wellements.com. The recalled Iron Drops Sample was distributed from 5.1.2019 to 7.22.2020 nationwide through promotional giveaways in select consumer purchases and select partners. Wellements Iron Drops are indicated for use in Infants 4 months to Children 3 years of age.

Wellements Iron Drops are sold in a 1oz glass amber bottle and packaged in an individual product carton that includes a 1ml oral syringe dispenser. The Wellements Iron Drops Sample is contained in a 1oz glass amber bottle filled to 2ml and packaged in an individual “SAMPLE- NOT FOR RESALE” product carton that includes a 1ml oral syringe dispenser.

The recalled products lot coding is located on the bottom of the bottle in yellow ink and on the side, towards the bottom of the carton in black ink. The recalled product coding is as follows:

Iron Drops Lot 18491 BB 1/2021

Iron Drops Lot 10592 BB 10/2020

Iron Drops Sample Lot 10592 BB 10/2020

There has been one allergic reaction reported to Wellements to date. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Undeclared methanol
Company Name:
Real Clean Distribuciones SA de CV
Brand Name:
Born Basic, Scent Theory and more
Product Description:
Hand Sanitizer

Company Announcement

La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntarily 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, and
  • 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 Product Country of Origin Size Lot Numbers
Real Clean Distribuciones S.A. De C.V. Scent Theory Keep Clean Hand Sanitizer 70% Alcohol Mexico 16.9oz 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
Real Clean Distribuciones S.A. De C.V. Keep it Clean Hand Sanitizer 70% Alcohol Mexico 16.9oz 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 16.9oz 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 34oz 0133420, 0233420, 0333420, 0433420, 0533420, 0633420
Real Clean Distribuciones S.A. De C.V. Born Basic Anti-Bac Hand Sanitizer 70% Alcohol Mexico 9.5oz 0133720, 0233720
Real Clean Distribuciones S.A. De C.V. Lux Eoi Hand Sanitizing Gel Mexico 16.9oz 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. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared Milk
Company Name:
UpSpring LLC
Brand Name:
UpSpring
Product Description:
“UpSpring Baby Iron + Immunity” dietary supplements

Company Announcement

UpSpring LLC of Austin, TX is recalling one batch of its 60 ml dark brown glass bottles sold in cartons of “UpSpring Baby Iron + Immunity” dietary supplements because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

UpSpring Baby Iron + Immunity dietary supplements were distributed nationwide via UpSpringBaby.com, Amazon.com and Target as well as in other retail stores and online channels between May 02, 2019 and July 17, 2020.

The recalled product comes in a 60 ml dark brown glass bottle within a carton with lot # 06691 and with an expiration date of March 2021. The lot # and expiration date can be located on the bottom of the carton in black ink and at the bottom of the glass bottle in yellow ink.

No allergic reaction has been reported to date with this product. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Potential presence of methanol (wood alcohol)
Company Name:
Maquiladora Miniara, S.A. de C.V.
Brand Name:
Shine & Clean
Product Description:
Hand Sanitizer Gel

Company Announcement

Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

Risk Statement: Substantial methanol exposure can 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 accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning Maquiladora Miniara S.A. de C.V. has not received any reports of adverse events related to this recall.

These products are used as topical hand sanitizers. The affected Shine and Clean Hand Sanitizer Gel is packaged in 1000 ml bottles and 1-gallon containers. Lot numbers:

F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/
D2028753/D202528742/D202428733/ D202028689/ D201828660/ D202428734/E200128784/E200418795/
D202428734/D202828689/D201828660/E201628912/E201628913/E201628911/E201528902/E201528903/
E201628910/E201628918/E201628914/E201628915/E201628916/E201628917/ E202328969/E202428975/
E202528981 /E202128947/ E201728918/E201728919/E201428876/ E201828894/ E201828920/
E201428876/E201128850/E201328859/E200628817/E200828826/E200928840/D202128699/D202428700.

Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared Egg
Company Name:
Whole Foods Market
Brand Name:
Whole Foods
Product Description:
Kouign-amann pastries

Company Announcement

Whole Foods Market is voluntarily recalling Kouign-amann pastries in 35 stores across Colorado, Kansas, Missouri, Nebraska, New Mexico, Texas and Utah due to undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

The pastries were distributed in the bakery department of select Whole Foods Market stores in Colorado, Kansas, Missouri, Nebraska, New Mexico, Texas and Utah. They were available in plastic clamshell 4-packs with Whole Foods Market scale labels, a PLU code of 267394 and a sell through date of July 27, 2020. All affected product has been removed from store shelves.

No allergic reaction has been reported to date. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared almond
Company Name:
Whole Foods Market
Brand Name:
Whole Foods
Product Description:
Chantilly Key Lime Tartlets

Company Announcement

Whole Foods Market is voluntarily recalling Chantilly Key Lime Tartlets from stores in Connecticut, Maine, Massachusetts, New Hampshire and Rhode Island due to an undeclared tree nut (almond) allergen. People who have a food allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.

The affected products were sold in the bakery department of select Whole Foods Market stores in Connecticut, Maine, Massachusetts, New Hampshire and Rhode Island. The product was individually packaged in plastic clamshell containers with Whole Foods Market scale labels, a PLU code of 268564, and product sell-by date through July 26, 2020. All affected product has been removed from store shelves.

No allergic reactions have been reported to date. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Cross contamination with lidocaine
Company Name:
Fresenius Kabi USA
Brand Name:
Fresenius Kabi
Product Description:
Dexmedetomidine Hydrochloride Injection, 200 mcg/50 mL

Company Announcement

Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Potential to contain mold
Company Name:
Hostess Brands LLC
Brand Name:
Hostess
Product Description:
Raspberry Zingers

Company Announcement

Hostess Brands, LLC (“Hostess Brands”) is voluntarily recalling certain Hostess® Raspberry Zingers® because the product may develop mold prior to the best by date.

This recall applies to the following Raspberry Zinger® products:

Product Item UPC Batch Best By Date
Hostess Raspberry Zingers (Multi-Pack fresh) 888109110604 H061224000 08/26/2020
H061324000 08/27/2020
H061424000 08/28/2020
H061524000 08/29/2020
Hostess Raspberry Zingers (Multi-Pack frozen) 888109110604 H061524000
Hostess Raspberry Zingers (Single-Serve fresh) 888109010089 H061224000 08/26/2020
H061324000 08/27/2020
H061424000 08/28/2020
Hostess Raspberry Zingers (Single-Serve frozen) 888109010089 H061424000
H061524000
Hostess Raspberry Zingers (Single-Serve grocery 3 count) 888109010089 H061224000 8/26/2020

The products were sold to mass merchandisers, grocery stores, distributors, dollar and discount stores, and convenience stores throughout the United States.

Consumers who have purchased the affected product are urged to discontinue consumption and contact the place of purchase about returning them for a full refund. (more…)