Month: February 2020

Summary

Company Announcement Date:
February 13, 2020
FDA Publish Date:
February 25, 2020
Product Type:
Animal & Veterinary
Animal Feed
Reason for Announcement:
Contains residue of unapproved herbicide (Haloxyfop)
Company Name:
Hubbard Feeds
Brand Name:
Hubbard Feeds
Product Description:
Easy Feed products and Organic Ground Flaxseed ORG

Company Announcement

No other products are affected.

Hubbard Feeds is voluntarily recalling products as the result of an ingredient-supplier recall. (more…)

Summary

Company Announcement Date:
February 24, 2020
FDA Publish Date:
February 24, 2020
Product Type:
Dietary Supplements
Reason for Announcement:
Product is tainted with sildenafil
Company Name:
Med Man Distribution
Brand Name:
Up2 and Bow & Arrow
Product Description:
Up2 THERE IS NO OTHER All Natural Libido for Men & Women Dietary Supplement and Bow and Arrow libido enhancer for men

Company Announcement

On 11/8/2019, Med Man Distribution voluntarily recalled all lots of Up2 dietary supplement. The recall has expanded to include all lots of dietary supplement Bow and Arrow libido enhancer for men to the consumer level.

FDA laboratory analysis has found Up2 Dietary supplement and Bow and Arrow to contain undeclared sildenafil. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The presence of sildenafil in Up2 and Bow and Arrow products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.

This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels which can be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, Med Man has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
February 24, 2020
FDA Publish Date:
February 24, 2020
Product Type:
Food & Beverages
Soup
Allergens
Reason for Announcement:
Product contains undeclared gluten
Company Name:
Sierra Soups
Brand Name:
Sierra Soups
Product Description:
Pasta e Fagioli

Company Announcement

Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of “Pasta e Fagioli” because the soup mix contains an individually wrapped package of pasta, which contains gluten. However outer packaging states the product is Gluten Free. People who have allergies to gluten run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled “Pasta e Fagioli” were distributed in Nationwide in retail stores and through mail orders.

The product comes in a 13 ounce, clear plastic package bearing the product name as well as the statement “Gluten-Free (without Pasta)”.

No illnesses have been reported to date in connection with this problem. (more…)

Name of product:
Aura and Silas 3-Drawer Chests
Hazard:

The recalled chests are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.

Remedy:
Refund
Recall date:
February 26, 2020
Units:
About 760
Consumer Contact:

Safavieh toll-free at 866-422-9070 from 9 a.m. to 5 p.m. ET Monday through Friday, email at cs@Safavieh.com or online at www.Safavieh.com and click on “Safety Notice” at the top of the Home Page.

Recall Details

Description:

This recall includes Safavieh, Aura and Silas 3-drawer chests with light gray drawers and light gray linen finish (Model Number CHS6410B), champagne drawers and mirror finish (Model Number CHS6403A), and steel teal drawers with mirror finish (Model Number CHS6403C). Each chest is about 32 inches wide, 16 inches deep and 29 inches tall.

Remedy:

Consumers should immediately stop using any recalled chest that is not properly anchored to the wall and place it in an area that children cannot access.  Safavieh will provide packaging and pre-paid shipping labels so that consumers can remove the chest’s drawer slides and return them to the firm for a full refund.

Incidents/Injuries:

None reported. (more…)

Summary

Company Announcement Date:
February 20, 2020
FDA Publish Date:
February 21, 2020
Product Type:
Drugs
Reason for Announcement:
Possible underdosing or overdosing
Company Name:
Taro Pharmaceuticals U.S.A., Inc.
Brand Name:
Taro Pharmaceuticals U.S.A., Inc.
Product Description:
Phenytoin Oral Suspension USP, 125 mg/5 mL

Company Announcement

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and is packaged in amber plastic bottles with an inner seal and a white child proof closure, and each bottle contains 237 mL. The reason for the recall is that product from these two lots of Phenytoin Oral Suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. This recall is being conducted with the knowledge of the FDA.

The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening status epilepticus requiring immediate emergency room treatment. To date, Taro has not received any adverse event reports related to this recall. (more…)

Summary

Company Announcement Date:
February 21, 2020
FDA Publish Date:
February 21, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared milk
Company Name:
Moonstruck Chocolate Co.
Brand Name:
Moonstruck
Product Description:
Praline Pecan & Ginger Element Bar in Dark Chocolate

Company Announcement

Moonstruck Chocolate Co. of Portland, Oregon is recalling 1,500 / 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.

The affected Moonstruck Chocolate Praline Pecan & Ginger Element Bar in Dark Chocolate was distributed nationwide through retail stores, online orders, and direct delivery between November 9, 2019 and February 19, 2020.

The Praline Pecan & Ginger Element Bar in Dark Chocolate is sold in a kraft box, net wt. 3.1 oz. The product SKU number is 312806 and the UPC code is 7 11175 12328 8. The product is also sold in a gold caddy. The box has a SKU number of 312806 and the UPC code is 10711175128068.

The affected best by dates are between 8/11/2020 and 10/10/2020. The affected lot numbers are 1101242, 1101731, 1101734, 1102664, 1102708, 1102754, and 1102914.

No illnesses have been reported to date. (more…)

Summary

Company Announcement Date:
February 20, 2020
FDA Publish Date:
February 20, 2020
Product Type:
Medical Devices
Reason for Announcement:
Catheter balloon may not deflate as intended
Company Name:
Abbott
Brand Name:
Abbott
Product Description:
Coronary dilatation catheters

Company Announcement

Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully undergone cardiac procedures using these devices.

Abbott issued a Field Safety Notice (FSN) External Link Disclaimeron Jan. 29, 2020, to physicians and hospitals who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products. The affected products were manufactured between July 29, 2019 – Dec. 19, 2019 and distributed between Aug. 16, 2019 – Jan. 3, 2020. The total number of distributed units from identified lots potentially affected is 40,429.

Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart. The balloons from the impacted lots may not deflate as intended. Potential risks include prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional intervention, such as surgery that could lead to post-operative complications which include death.

The FDA has classified this as a Class I recall. The frequency of reported events that include slow, partial and failure to deflate the balloon, is 0.12 percent worldwide. At the time the FSN was issued, there were no reports of patient death. Since the issuance of the FSN, Abbott has become aware of one reported case in which the inability to deflate the balloon necessitated intervention, which resulted in post-procedural complications leading to a patient death. (more…)

Summary

Company Announcement Date:
February 20, 2020
FDA Publish Date:
February 20, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared almonds
Company Name:
Vitamin Cottage Natural Food Markets, Inc.
Brand Name:
Natural Grocers
Product Description:
Peanut clusters dark chocolate Non GMO

Company Announcement

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Peanut Clusters Dark Chocolate Non-GMO because the product contains undeclared almond allergen. People who have an allergy or severe sensitivity toalmonds run the risk of serious or life-threatening allergic reaction if they consume these products. Consumers who may have purchased this product are advised to discontinue use and either throw it away or return it to the store for credit or refund.

The recalled product is packaged in clear plastic bags weighing 8 ounces and bearing the “Natural Grocers” label. Pack dates between 2019 and 20-048 being recalled at this time.

There have been no reports of illness or injury to date, but Natural Grocers is acting out of an abundance of caution to notify consumers and recall any of the affected product in the marketplace. (more…)

Summary

Company Announcement Date:
February 20, 2020
FDA Publish Date:
February 20, 2020
Product Type:
Food & Beverages
Reason for Announcement:
Peanut clusters dark chocolate Non GMO
Company Name:
Dr. Praeger’s Sensible Foods, Inc.
Brand Name:
Natural Grocers
Product Description:
Almond clusters dark chocolate Non GMO

Company Announcement

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Almond Clusters Dark Chocolate Non-GMO because the product contains undeclared peanut allergen. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Consumers who may have purchased this product are advised to discontinue use and either throw it away or return it to the store for credit or refund.

The recalled product is packaged in clear plastic bags weighing 8 ounces and bearing the “Natural Grocers” label. Pack dates between 2019 and 20-035 are being recalled at this time.

There have been no reports of illness or injury to date, but Natural Grocers is acting out of an abundance of caution to notify consumers and recall any of the affected product in the marketplace. (more…)

Name of product:
Browning Leather Pistol Holsters
Hazard:

The holster design can change the position of the safety switch on the firearm without the user knowing it. When this occurs, if the trigger is accidentally pulled, the firearm could fire unexpectedly, posing an injury hazard to the user and bystanders.

Remedy:
Replace
Recall date:
February 20, 2020
Units:
About 1,265
Consumer Contact:

Browning at 800-945-5372 from 8 a.m. to 4:30 p.m. MT Monday through Friday, email HolsterRecall@browning.com, online at www.browning.com and click on the “News/Recalls” tab, or visit https://www.browning.com/support/recall-safety-information/recall-notice—-leather-holster–multi-angle-thumb-break.html.

Recall Details

Description:

This recall involves the Browning Leather Pistol Holsters, Multi-Angle Thumb Break, which is a leather pistol holster designed to carry Browning 1911-380 and 1911-22 pistols.  The holsters are brown with yellow stitching with the Browning buckmark logo branded on the front of the holster. The holsters can be identified by Item No. 12904011 and UPC Code 023614843702, which are printed on the back of the product packaging. Contact Browning with any questions regarding the identification of the recalled holsters.

Remedy:

Consumers should immediately stop using the recalled holsters and contact Browning for a free replacement.

Incidents/Injuries:

Browning has received one report where the holster design changed the position of the safety switch on the firearm.  No injuries have been reported. (more…)