Condies Foods Issues Allergy Alert on Undeclared Soy Allergen in Chicken Salad on Croissant Single Item# 43237 and Chicken Sandwich on White Single Item# 43559

Posted by jbushland on

Summary

Company Announcement Date:
April 29, 2020
FDA Publish Date:
April 29, 2020
Product Type:
Food & Beverages
Allergens
Reason for Announcement:
Undeclared soy
Company Name:
Condies Foods
Brand Name:
Condies Foods
Product Description:
Chicken salad sandwiches

Company Announcement

Condies Foods of Kearns, UT is recalling 165 units of roll chicken salad on croissant single item# 43237 “USE THRU” 03/6/2020 – 05/6/2020, and sndw chicken sandwich on white single item# 43559 “USE THRU” 03/6/2020 – 05/2/2020. There is a possibility that these may contain undeclared soy allergen. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products: roll chicken salad on croissant single item# 43237 “USE THRU” 03/6/2020 – 05/6/2020, and sndw chicken sandwich on white single item# 43559 “USE THRU” 03/6/2020 – 05/2/2020.

Product was distributed to Coremark Distribution centers that distributed product to 18 stores, Utah state wide.

The product labels look as follows: (see below)

The description of the products in question are:

Roll chicken salad on croissant single item# 43237 Label UPC: 50777445351 and sndw chicken sandwich on white single item# 43559 Label UPC: 50777444804

A wrong ingredient was purchased and used; this ingredient chicken chunks contains soy and was not declared originally in the labels.

The code dates “USE THRU” 03/6/2020 – 05/6/2020, and “USE THRU” 03/6/2020 05/2/2020.

There have been no documented illnesses at this time. (more…)

CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets

Posted by jbushland on

Summary

Company Announcement Date:
April 27, 2020
FDA Publish Date:
April 29, 2020
Product Type:
Medical Devices
Reason for Announcement:
pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
Company Name:
CME America
Brand Name:
CMEAmerica BodyGuard
Product Description:
Infusion pumps and infusion sets

Company Announcement

CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device’s infusion sets (FDA Recall Number: Z-1442-2020).

Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market. The following is a summary of each individual product recall (more…)

GSK Consumer Healthcare Recalls Benefiber Healthy Shape Prebiotic Fiber Supplement and Benefiber Prebiotic Fiber Supplement Due to Possible Plastic Contamination from the Bottle Cap

Posted by jbushland on

Summary

Company Announcement Date:
April 28, 2020
FDA Publish Date:
April 28, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Potential for plastic pieces or shavings
Company Name:
GSK Consumer Healthcare
Brand Name:
Benefiber
Product Description:
Prebiotic Fiber Supplement

Company Announcement

GSK Consumer Healthcare is voluntarily recalling five lots (listed below) of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be present in the product. There is a potential risk of choking or physical injury to the soft tissues of the mouth or gastrointestinal tract of a consumer using the product who may not see a broken piece or shaving of plastic cap.

These lots were distributed from October 28, 2019 through January 21, 2020 within the United States to retail stores and online retailers nationwide. The recall is limited to the five lots listed below:

Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872 Lot: MP8B (EXP Sep2021) Benefiber Prebiotic Fiber Supplement, 500G UPC 886790218302 Lots: YT2Y (EXP Oct2021) 7D6E (EXP Nov2021) Benefiber Prebiotic Fiber Supplement, 760G UPC 8886790211907 Lots: UV5C (EXP Oct2021) 648H (EXP Nov2021)
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As of the date of the recall announcement, GSK Consumer Healthcare has received one consumer complaint of a green particle observed inside a bottle of product. (more…)

Leviton Manufacturing Recalls Electrical Connection Devices Due to Shock Hazard

Posted by jbushland on
Name of product:
Leviton 50 ampere, non-NEMA electrical connectors, plugs, receptacles and inlets
Hazard:

The electrical connection devices can have mislabeled terminal markings, posing an electrical shock hazard.

Remedy:
Replace
Recall date:
April 23, 2020
Units:
About 98,000 (In addition, about 4,400 units were sold in Canada)
Consumer Contact:

Leviton toll-free at 877-978-2032 from 8 a.m. to 6 p.m. ET Monday through Friday or online at www.Leviton.com and click on “Recall Information” for more information.

Recall Details

In Conjunction With:
Description:

This recall involves Leviton 50-ampere, non-NEMA electrical connectors, plugs, receptacles and inlet attachment devices. The recalled connection devices are used to transmit power to electrical equipment that is not hard-wired to a power source. Leviton is printed on the devices. Date codes can be found on the back cover of connectors and plugs, the side housing of receptacles and inlets, and on the label of each box. The recall includes the following model/catalog numbers and date codes:

CATALOG NUMBERS

DATE CODES

3762C

CS6365C

1E19C0

1I19C0

3763C

CS6365W

1E29C0

1I29C0

3764C

CS6369

1E39C0

1I39C0

3765C

CS6370

1E49C0

1I49C0

3769

CS6375

1E59C0

1I59C0

3771

CS6377

1F19C0

1J19C0

3775

CS8264C

1F29C0

1J29C0

3777

CS8265C

1F39C0

1J39C0

6360CR

CS8269

1F49C0

1J49C0

6364CR

CS8275

1G19C0

1K19C0

6365CR

CS8464C

1G29C0

1K29C0

6369CR

CS8465C

1G39C0

1K39C0

6370CR

CS8469

1G49C0

1K49C0

6375CR

CS8164C

1H19C0

1K59C0

7379

CS8165C

1H29C0

1L19C0

7764C

CS8169

1H39C0

1L29C0

7765C

CS8175

1H49C0

7958

CS8364C

CS6360C

CS8365C

CS6361C

CS8369

CS6364C

CS837-410-5W1

CS6364W

CS8375

Only electrical connectors without a blue dot on the device and packaging are included in this recall.

Remedy:

Consumers should immediately stop using the recalled devices, disconnect power to them and contact Leviton to arrange for a free replacement device.

Incidents/Injuries:

Leviton has received four reports of mismarked devices, including one report of a consumer who received an electrical shock, and three reports of minor property damage to equiptment with which the devices were being used. (more…)

BioFinest Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively at Biofinest.com (Recall Alert)

Posted by jbushland on
Name of product:
BioFinest Wintergreen Essential Oil
Hazard:

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

Remedy:
Refund
Recall date:
April 23, 2020
Units:
About 20
Consumer Contact:

BioFinest toll-free at 888-726-5171 from 10 a.m. to 5 p.m. MT Monday through Friday, email at support@biofinest.com, or online at www.biofinest.com and click on Recall for more information.

Recall Details

Description:

This recall involves 1/3 fl. oz (10 mL) and 3.3 fl. oz (100 mL) amber glass bottles with black caps of BioFinest Wintergreen Essential Oil. The 100 mL bottles include a dropper. The white label on the bottle displays the BioFinest logo, product name and the volume amount of the bottle. The UPC codes 759578392443 (10 mL) and 759578392436 (100 mL) are printed on the bottle’s label.

Remedy:

Consumers should immediately store the product in a safe location out of reach of children. Contact BioFinest for instructions on how to dispose of the product and receive a full refund. Biofinest is contacting all known purchasers directly.

Incidents/Injuries:

None reported (more…)

LUS Recalls Hair Dryers Due to Electrocution or Shock Hazard (Recall Alert)

Posted by jbushland on
Name of product:
LUS Hair Dryers & Diffusers
Hazard:

The hair dryers do not have an immersion protection device, posing an electrocution or  shock hazard if the dryer falls into water when plugged in.

Remedy:
Refund
Recall date:
April 23, 2020
Units:
About 2,700 (In addition, about 410 were sold in Canada)
Consumer Contact:

LUS at 800-280-1675, by email at support@lusbrands.ca, or online at www.lusbrands.com and click on ‘Safety and Recall Information’ for more information.

Recall Details

In Conjunction With:
Description:

This recall involves the LUS Dryer & Diffuser. The handheld hair dryers were sold in white, in a box that also contains a diffuser. The hair dryers have the model number HD-LUS01 printed under the back end of the hair dryer. The logos “LUS Brands” and “Love Ur Curls” are located on either side of the back end of the dryer.

Remedy:

Consumers should immediately stop using and unplug the hair dryers.  LUS is contacting all known purchasers of the hair dryers and providing a choice of either a full refund of the purchase price or a $175 store credit.

Incidents/Injuries:

None reported (more…)

Naturo Sciences Recalls Eiji Essentials Wintergreen Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

Posted by jbushland on
Name of product:
Eiji Essentials Wintergreen Essential Oil
Hazard:

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

Remedy:
Refund
Recall date:
April 23, 2020
Units:
About 1,200
Consumer Contact:

Naturo Sciences toll-free at 800-656-0273 from 9 a.m. to 5 p.m. PT Monday through Friday, email at support@naturosciences.comor online at www.naturosciences.com and click on ‘Naturo Sciences Eiji Wintergreen Oil Recall Alert’ for more information. Put “Refund” in the subject line of the e-mail and in the body provide your name, address, and photo of the product.

Recall Details

Description:

This recall involves Wintergreen Essential Oil in a 5 mL amber glass bottle with a black cap and red and black label. “Eiji,” “Wintergreen”, “100% Pure Essential Oil,” and the volume amount of the bottle are printed on the label. The Eiji logo is printed in blue and product name in white. The lot number 6321C is printed on the bottom of the bottle.

Remedy:

Consumers should immediately store the product in a safe location out of reach of children and contact Naturo Sciences for a refund. The firm is directly notifying all known purchasers about the recall.

Incidents/Injuries:

None reported (more…)

Fresenius Kabi’s Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

Posted by jbushland on

Summary

Company Announcement Date:
April 23, 2020
FDA Publish Date:
April 27, 2020
Product Type:
Drugs
Reason for Announcement:
presence of particulate matter
Company Name:
QuVa Pharma, Inc.
Brand Name:
QuVa
Product Description:
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe

Company Announcement

SUGAR LAND, Texas, April 23, 2020 — QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi. Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials.

QuVa has reached out to all hospital pharmacy customers who purchased product from the lots affected and has asked them to: quarantine anything that is in stock to prevent use in direct patient care; complete a return response form to capture the amount of unused product; and return the finished goods to QuVa for destruction. (more…)

Royal International Trading Inc Issues Alert On Undeclared Sulfites In “Tayni Boctoka Dry Fruits Mix Compot Apple”

Posted by jbushland on

Summary

Company Announcement Date:
April 22, 2020
FDA Publish Date:
April 22, 2020
Product Type:
Food & Beverages
Fruit/Fruit Product
Allergens
Reason for Announcement:
Undeclared Sulfites
Company Name:
Royal International Trading Inc.
Brand Name:
Royal International Trading Inc.
Product Description:
“TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE”

Company Announcement

ROYAL INTERNATIONAL TRADING Inc of Brooklyn, NY is recalling its 500g (17.63oz) packages of “TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE” because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

The recalled “TAINY BOCTOKA DRY FRUITS MIX COMPOST APPLE” were distributed nationwide in retail stores and through mail orders. The product comes in 500g (17.63oz) clear plastic package marked with container code 4705932006197.

No illness or allergic reactions involving this product have been reported to date. (more…)

Ocean Spray Cranberries, Inc Recalls Single Production Lot of 5.5 Oz Cans of Pink Lite Cranberry Juice Drink Because of Undeclared Sulfites

Posted by jbushland on

Summary

Company Announcement Date:
April 21, 2020
FDA Publish Date:
April 21, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared Sulfites
Company Name:
Ocean Spray Cranberries, Inc.
Brand Name:
Ocean Spray
Product Description:
Pink Lite Cranberry Juice Drink

Company Announcement

Ocean Spray Cranberries, Inc. is recalling a single production lot of 5.5oz cans of Pink Lite Cranberry Juice Drink (listed below) because it may contain undeclared sulfites, which were erroneously added by a contract manufacturer. Sulfites are a common preservative added to many food products; however, consumers who have sensitivity to sulfites run the risk of allergic reactions if consumed. Most people will not experience any effect if they consume this ingredient. No illnesses have been reported to date. (more…)