Month: September 2020

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Company Name:
Sun Pharmaceutical Industries
Brand Name:
Riomet ER
Product Description:
Metformin Hydrochloride for Extended-Release Oral Suspension

Company Announcement

Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.  To date, SUN PHARMA 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:
Product has the potential to be contaminated with Salmonella
Company Name:
Wismettac Asian Foods, Inc.
Brand Name:
Shirakiku
Product Description:
Dried Fungus (also known a Black Fungus or Kikurage)

Company Announcement

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is issuing a voluntary recall for Shirakiku brand imported Dried Fungus (also known as Black Fungus or Kikurage) because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Animal Feed
Reason for Announcement:
Salmonella
Company Name:
Real Pet Food Company
Brand Name:
Billy+Margot Wild Kangaroo and Superfoods Recipe
Product Description:
Dog food

Company Announcement

Real Pet Food Company is voluntarily recalling Billy+Margot Wild Kangaroo and Superfoods Recipe 4lb bags because it has the potential to be contaminated with SalmonellaSalmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products.

While no illnesses have been reported, healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Owners exhibiting any signs after having contact with this product should contact their healthcare provider. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Undeclared pecans
Company Name:
Homestead Creamer
Brand Name:
Homestead Creamery
Product Description:
Chocolate Ice Cream

Company Announcement

Homestead Creamery of Wirtz, VA is recalling one lot of Homestead Creamery chocolate ice cream quarts, dated 5/13/2021, because it may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products.

The chocolate ice cream quarts were distributed in Virginia and North Carolina in May through retail stores and direct delivery.

The date of the ice cream is located on the bottom of the container.

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

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Prepared Food
Allergens
Reason for Announcement:
Undeclared milk and egg
Company Name:
GHSW, LLC
Brand Name:
Trader Joe’s
Product Description:
Southwest Style Sweet Potato Saute Bowl

Company Announcement

GHSW, LLC. is voluntarily recalling 1512 units of Trader Joe’s Southwest Style Sweet Potato Sauté Bowl due to undeclared milk and egg allergens in the dressing that are not declared on the label.  People who are allergic to milk and eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

The dressing is located in a pouch found inside the clear 21.5 oz. bowl.  These bowls are sold in the refrigerated section of the store.

The recalled product(s) were shipped to 36 Trader Joe’s stores in the following states:  AR, CO, KS, LA, NM, OK, TN, and TX.

The recall has been isolated to only Southwest Style Sweet Potato Sauté Bowl with the Best By dates 09/23/20, 09/24/20, 09/25/20, 09/26/20, and 09/28/20 on the front of the package. No other products or lots are affected by this recall.

No reports of illnesses or injury have been received to date. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Potential for four hardware situations that may result in the infusion pump not operating as expected
Company Name:
Becton, Dickinson and Company
Brand Name:
Alaris
Product Description:
BD Alaris System Hardware

Company Announcement

Three Recalls Designated as Class I by FDA; One Designated as Class II

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on  previously announced voluntary recalls of the BD Alaris™ System.

Three of the recalls, which BD announced on Aug. 4, 2020External Link Disclaimer,External Link Disclaimer have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Sub Potency
Company Name:
Acella Pharmaceuticals, LLC
Brand Name:
NP Thyroid 15 & NP Thyroid120
Product Description:
Thyroid Tablets

Company Announcement

Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updatesExternal Link Disclaimer.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall. (more…)

Name of product:
Vthrive Bioactive Women’s One-Daily Multi vitamins
Hazard:

The multivitamins’ packaging is not child resistant as required by the Poison Prevention Packaging Act.  The capsules inside the bottle contain iron, which can cause serious injury or death to young children if multiple tablets are ingested at once.

Remedy:
Refund
Recall date:
September 24, 2020
Units:

About 8,200

Consumer Contact:

The Vitamin Shoppe toll-free at 866-293-3367 from 9 a.m. to 9 p.m. ET Monday through Sunday, email at Bioactiverecall@vitaminshoppe.com, or online at www.vitaminshoppe.com and click on Product Recall Alert or www.vitaminshoppe.com/u/contact-us for more information.

Recall Details

Description:

This recall involves The Vitamin Shoppe’s Vthrive Bioactive Women’s One-Daily Multi vitamins.  The 60-count capsules were sold in an amber bottle with a gray top.  Vthrive and Bioactive Women’s One-Daily Multi are printed on a blue label on the bottle.  Item number VS-6104 can be found on the back of the bottle and lot number 006218, 006454, 006495 or 006779 on the bottle’s underside.  Only the 60-count bottles are included in this recall.

Remedy:

Consumers should immediately store the product in a safe location out of reach of children.  Contact The Vitamin Shoppe for instructions on how to dispose of the product and receive a full refund or merchandise credit.  The Vitamin Shoppe is notifying all known purchasers directly.

Incidents/Injuries:

None reported. (more…)

Name of product:
2020 and 2021 ZFORCE 950 Sport Recreational Off-Highway Vehicles (ROVs)
Hazard:

The throttle gas pedal can fail to return quickly to the idle position which can create a crash hazard if the vehicle does not slow down as quickly as expected by the driver when the gas pedal is released. The throttle gas pedal can fail to return quickly to the idle position which can create a crash hazard if the vehicle does not slow down as quickly as expected by the driver when the gas pedal is released.

Remedy:
Repair
Recall date:
September 24, 2020
Units:

About 627 (2020 ROVs were previously recalled for a fire hazard on 09/03/2020)

Consumer Contact:

CFMOTO toll-free at 888-823-6686 from 8 a.m. to 5 p.m. CT, Monday through Friday, email at info@cfmotousa.com or online at www.cfmotousa.com and go to Customer Care, then Vehicle Recall for more information.

Recall Details

Description:

This recall involves the 2020 and 2021 ZFORCE 950 Sport ROV with a 963cc 4-cycle engine.  Vehicles colors are red, silver or gray with the CFMOTO logo in the center of the front grille.  The model name is located on each side of the vehicle doors.  The model year 2020 ROVs will have the letter L in the 10th position of the vehicle identification number (VIN).  The model year 2021 ROVs will have the letter M in the 10th position of the vehicle identification number (VIN).  The VIN number is stamped on the right-side frame rail, behind the right rear tire.

Remedy:

Consumers should immediately stop using the recalled ROVs and contact a CFMOTO dealer to schedule a free repair.  CFMOTO is contacting all registered owners and dealers directly.

Incidents/Injuries:

CFMOTO has received two reports of the throttle pedal assembly malfunctioning.  No injuries have been reported. (more…)

Name of product:
Kobalt brand 40-volt Lithium Ion 8-inch Cordless Electric Pole Saws
Hazard:

The switch on the recalled pole saws can fail while under a heavy load, and cause the unit to continue running after the user releases the trigger, posing a laceration hazard to consumers.

Remedy:
Repair
Recall date:
September 23, 2020
Units:

About 106,400 (In addition, 120 in Canada)

Consumer Contact:

Hongkong Sun Rise Trading toll-free at 855-378-8826 Monday through Thursday from 9 a.m. to 8 p.m. ET, Friday through Sunday from 9 a.m. to 5 p.m. ET, or online at www.greenworkstools.com and click on “Important Safety Notice.”

Recall Details

In Conjunction With:
Description:

This recall involves Kobalt brand 40-volt lithium ion 8-inch cordless electric pole saws manufactured from January 2017 through February 2019.  Date codes from 01/01/17 to 02/28/19 are included in the recall.  The item number and date code are printed on the side of the guide bar near the oil cap.  Kobalt is printed on the side of the unit.

Item Number

Description

796791

Kobalt 49v 2.5AH Pole Saw

1083769

Kobalt 40v Pole Saw Bare Tool

970801

40v Pole Hedge Saw Combo Kit

812419

SOS Kobalt 40v Pole Saw

812424

SOS Kobalt 40v Pole Saw Tool Only

 

Remedy:

Consumers should immediately stop using the recalled pole saws and contact Hongkong Sun Rise Trading for a free repair.

Incidents/Injuries:

Hongkong Sun Rise Trading has received 65 reports of the saws continuing to run.  No injuries have been reported. (more…)