Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Summary

Company Announcement Date:
December 17, 2019
FDA Publish Date:
December 17, 2019
Product Type:
Drugs
Reason for Announcement:
NDMA (Nitrosodimethylamine) impurity
Company Name:
Glenmark Pharmaceuticals, Inc.
Brand Name:
Glenmark
Product Description:
Ranitidine Tablets 150mg and 300mg

Company Announcement

Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.

The recalled lots of Ranitidine Tablets 150 mg and 300 mg, which are listed in Attachment B, are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall. (more…)

Motto International Corp. Issues Voluntary Recall of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, Due to Presence of Undeclared Tadalafil

 

Summary

Company Announcement Date:
December 17, 2019
FDA Publish Date:
December 17, 2019
Product Type:
Drugs
Reason for Announcement:
Presence of Undeclared Tadalafil
Company Name:
Motto International Corp
Brand Name:
No Brand name Listed on Package
Product Description:
Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, Panther Platinum 30000

Company Announcement

Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer level. FDA analysis has found Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000 to be tainted with undeclared tadalafil. Tadalafil is an FDA approved drug indicated for the treatment of male sexual enhancement. The presence of tadalafil in these products renders them unapproved drugs for which safety and efficacy has not been established and, therefore, subject to recall.

Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin). The combination of tadalafil and nitrates may lower blood pressure to dangerous levels which can be life threatening. Consumers 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, Motto International Corp. has not received any reports of adverse events related to this recall. (more…)

J. Crew Recalls Boys’ Denim Pants Due to Aspiration and Choking Hazards

Name of product:
Crewcuts boys’ stone washed denim pants
Hazard:

Small stones can be present in the pockets or waistband of the pants from the stone washing manufacturing process, posing aspiration or choking hazards to young children.

Remedy:
Repair
Recall date:
December 17, 2019
Units:
About 900
Consumer Contact:

J. Crew at 800-261-7422 anytime, email at 24-7@jcrew.com or online at www.jcrew.com and click on “Product Recall Information: J.Crew boys’ stone-washed denim pants” at the bottom of the page for more information.

Recall Details

Description:

This recall involves Crewcuts boys’ denim pants sold in sizes 2 and 3 and only includes pants that were made in Pakistan.  Pants with style number J8406 and season FA 19 are included in the recall.  A care label sewn into the side seam lists the style number and season.  A label sewn into the waistband of the garment lists the size and country of origin and “Crewcuts.”  UPC codes 099105125419 and 099105125420 are listed on the price tag attached to the pants.

Remedy:

Consumers should immediately take the recalled pants away from children and remove the stones from pockets or internal waistband opening  to eliminate the hazard

Incidents/Injuries:

J. Crew received one report of stones found in the waistband extension of the pants. No injuries have been reported. (more…)

Hillsdale Furniture Recalls Five-Drawer Chests Due to Tip-Over and Entrapment Hazards

Name of product:
Chadwick and Bailey five-drawer chests
Hazard:

The chests are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.  The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-17).

Remedy:
Refund
Repair
Recall date:
December 18, 2019
Units:
About 31,000 (in addition, about 740 were sold in Canada)
Consumer Contact:

Chests purchased at Bob’s Discount Furniture contact toll-free at 800-569-1284 from 6:30 a.m. to 11p.m. ET Monday through Saturday or e-mail AskBob@mybobs.com.  Chests purchased at other retailers contact Hillsdale Furniture at 800-368-0999 from 9 a.m. to 5 p.m. ET Monday through Friday or e-mail recall@hillsdalefurniture.com or online at www.hillsdalefurniture.com and click on “Product Recalls” located at the bottom of the page for more information

Recall Details

In Conjunction With:
Description:

This recall includes Chadwick and Bailey five-drawer wood chests in white, mission oak, espresso and dove gray colors.  “Hillsdale Furniture” is printed on a label on the back of the chest.  The chests measure 48 inches tall by 36 inches wide by 17 inches deep.

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.  Contact Bob’s Discount Furniture or Hillsdale Furniture to receive a free repair or refund.  Remedy options include a free self-install repair kit, free in-home installation of repair kit or free pick-up of the chest.

Incidents/Injuries:

None reported. (more…)

Profile Design Recalls Bicycle Carbon Aerobars Due to Crash Hazard

Name of product:
Aeria Ultimate carbon aerobars
Hazard:

The bicycle aerobars can crack and break, causing the rider to lose control and crash.

Remedy:
Replace
Recall date:
December 11, 2019
Units:
About 260
Consumer Contact:

Profile Design toll-free at 888-800-5999 from 9 a.m. to 5 p.m. PT Monday through Friday or online at www.profile-design.com and click on “Recall Notices” or email AeriaUltimateRecall@profile-design.com for more information.

Recall Details

Description:

This recall involves Profile Design Aeria Ultimate carbon aerobars sold individually and as an original equipment upgrade on consumer configurable Dimond Brand Bikes and Quintana Roo model bicycles. The aerobars were sold in one size and are all matte black in color. “Profile Design” and “Ultimate” are embossed in gloss black on the top of the rear edge of the aerobars. The best way to identify recalled handlebars is to measure the uncut hand extensions from the leading edge of wing to tip of hand extension (where brake lever is placed). On recalled bars it is 13.6 cm (5.3 in) measured from leading edge of wing.

Remedy:

Consumers should immediately stop using bicycles with the recalled aerobars and contact Profile Design for instructions to receive a free replacement aerobar via their local retailer.

Incidents/Injuries:

The firm has received two reports of the bicycle aerobars cracking or breaking. No injuries reported. (more…)

Dole Fresh Vegetables Announces Precautionary Limited Recall of Colorful Coleslaw

Summary

Company Announcement Date:
December 03, 2019
FDA Publish Date:
December 03, 2019
Product Type:
Food & Beverages
Reason for Announcement:
Potential Salmonella Contamination
Company Name:
Dole Fresh Vegetables, Inc.
Brand Name:
President’s Choice, Marketside
Product Description:
Colorful Coleslaw

Company Announcement

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of Colorful Coleslaw. This precautionary recall notification is being issued due to a sample of President’s Choice Colorful Coleslaw which yielded a positive result for Salmonella in a random sample test conducted by the Canadian Food Inspection Agency.

Salmonella is an organism that can cause foodborne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, diarrhea, nausea, vomiting and abdominal pain. The illness primarily impacts young children, frail or elderly people, and others with weakened immune systems. Most healthy adults and children rarely become seriously ill after exposure to Salmonella.

The products being recalled are 14 oz President’s Choice Colorful Coleslaw, Lot codes B318005 and B318006 (UPC code 0-6038322267-3), with Use-by date of 2019 DE 04 and 16 oz Marketside Tri-Color Coleslaw, Lot codes B318005 and B318006 (UPC code 6-81131-38748-4), with Best if Used by date DEC 04 2019, due to a possible health risk from Salmonella. Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported in association with the recall to date. (more…)

Lin’s Waha Int’l Corp Issues Alert on Undeclared Sulfites and Cyclamates in “Suantianyangmei Waxberry and Bingtangyangmei Waxberry”

Summary

Company Announcement Date:
December 02, 2019
FDA Publish Date:
December 03, 2019
Product Type:
Food & Beverages
Fruit/Fruit Product
Allergens
Reason for Announcement:
Undeclared sulfites and cyclamates
Company Name:
Lin’s Waha Int’l Corp
Brand Name:
Lin’s Waha Int’l Corp
Product Description:
Suantianyangmei Waxberry and Bingtangyangmei Waxberry

Company Announcement

Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates. People who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products. Cyclamate is an unapproved ingredient.

The recalled Suantianyangmei Waxberry and Bingtangyangmei Waxberry were distributed nationwide in retail stores. These products come in 8.11 OZ (230G) clear plastic containers. Suantianyangmei Waxberry is with UPC code 6948576407226 and date 03.12.2020 stamped on the box and Bingtangyangmei Waxberry is with UPC code 6948576407219 and date 02.13.2020 stamped on the box.

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

The J. M. Smucker Company Issues Voluntary Recall of Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health Concerns

Summary

Company Announcement Date:
December 05, 2019
FDA Publish Date:
December 05, 2019
Product Type:
Animal & Veterinary
Pet Food
Target Animal – Safety
Reason for Announcement:
Products don’t meet the Company’s quality and safety standards
Company Name:
The J. M. Smucker Company
Brand Name:
Special Kitty
Product Description:
Wet, canned cat food

Company Announcement

The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards.

The specific product is Special Kitty® Mixed Grill Dinner Pate. In addition to being sold individually this product is also sold as part of variety packs. If pet parents have any of the products below in their possession, they should stop feeding it to their cats and dispose of the product.

Product Name Retail UPC Code Lot Code Best If Used By Date
Special Kitty® Mixed Grill Dinner Pate 5.5 oz. metal can 681131078962 9263803 9/19/2021
Product Name Retail UPC Code Lot Code Best If Used By Date
Special Kitty® Surf & Turf Variety Pack of Pate Cat Food in 5.5 oz metal cans 681131079235 9266803 7/17/2021
8/29/2021
9/11/2021
9/12/2021
Special Kitty® Surf & Turf Variety Pack of Pate Cat Food in 5.5 oz metal cans 681131079235 9267803 7/17/2021
8/29/2021
9/11/2021
9/12/2021
Special Kitty® Surf & Turf Variety Pack of Pate Cat Food in 5.5 oz metal cans 681131079235 9287803 9/12/2021
9/19/2021
10/7/2021

Ingesting impacted product may cause nausea with excessive salivation, diarrhea or vomiting to more severe symptoms including difficulty walking, seizures and, in extreme situations, death. Pet parents are encouraged to contact their cat’s veterinarian immediately if their cat is displaying any of these symptoms. (more…)

Nassau Candy Distributors Issues Allergy Alert on Undeclared Milk Allergen in Nancy Adams, Dark Chocolate Graham Crackers

Summary

Company Announcement Date:
December 04, 2019
FDA Publish Date:
December 05, 2019
Product Type:
Food & Beverages
Snack Food Item
Allergens
Reason for Announcement:
Undeclared Milk
Company Name:
Nassau Candy Distributors
Brand Name:
Nancy Adams
Product Description:
Dark Chocolate Graham Crackers

Company Announcement

Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or lifethreatening allergic reactions if they consume this product.

The recalled Nancy Adams, Dark Chocolate Graham Crackers UPC: 618645275860 was distributed to limited Retailers and Distributors Nationwide. The product cones in a brown paper bag packaging with a clear window with Best by and Best if Used by Dates of 4/30/20, 5/1/20, 5/21/20, 6/30/20, 8/4/20, stickered to the bottom of the bag.

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

Tropical Nut and Fruit Co. Issues Allergy Alert of Undeclared Soy and Tree Nut (Almonds) on Their Truly Good Foods South of the Border Mix

ummary

Company Announcement Date:
December 06, 2019
FDA Publish Date:
December 06, 2019
Product Type:
Food & Beverages
Snack Food Item
Allergens
Reason for Announcement:
Undeclared almond and soy
Company Name:
Tropical Nut and Fruit Co.
Brand Name:
Truly Good Foods
Product Description:
South of the Border nut mix

Company Announcement

Charlotte headquartered Tropical External Link DisclaimerNut and Fruit Co. is voluntarily recalling their 25lb box of Truly Good Foods South of the Border nut mix, Lot #29119, best by date 04/15/2020, item # 102340 and UPC # 094184110198 because it contains undeclared soy and tree nut (almonds). People who are allergic to soy or tree nuts run the risk of serious or life threating allergic reactions if they consume this product.

The voluntary recall was initiated after it was discovered that the wrong product was packaged inside the South of the Border box, therefore containing different allergens from what is stated on the label. The mislabeled product was distributed to stores between 10/21/2019 and 12/05/2019.

The mislabeled South of the Border mix was sent to select retail locations of specialty grocer The Fresh Market stores, where it was sold in the bulk bin section. The product was distributed only to retail stores in the following states: NC (excluding Ashville), SC (only Myrtle Beach and Pawley’s Island stores), VA, IN, OH, PA, MA, NY, MD, DE, NJ, CT KY AND IL. No other The Fresh Market locations are impacted.

This product has been removed from The Fresh Market’s shelves, and to date, no illnesses have been reported in connection with this recall. (more…)