Category Archives: Recall

Hummingbird Wholesale Issues Allergy Alert on Undeclared Milk in Organic Chocolate Hazelnut Butter

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hummingbird-1WASHINGTON — Hummingbird Wholesale in Eugene Oregon is recalling 110 jars of Hummingbird Brand Organic Chocolate Hazelnut Butter that may contain undeclared milk. People who have an allergy or severe sensitivity to milk products run the risk of serious or life threatening allergic reaction if they consume this product.

No illnesses have been reported to date.

The recalled product sold to retail outlets in California, Oregon, and Washington and directly to consumers in Oregon in 1 pound (454 gram) glass jars that show lot number of 15023 on a white sticker on the jar between the dates of 1/27/15 and 2/19/15.

HW Item # Lot # UPC Code
N270 15023 6-96859-11035-1

The recall was initiated after it was discovered that a supplier had changed the ingredients without notice to include milk in the 65% dark chocolate used to make the Organic Chocolate Hazelnut Butter. The label does not show milk as an ingredient. Only lot # 15023 was made with the affected chocolate.

Consumers who purchased this product are welcome to return it to the place of purchase for a full refund, or to contact Hummingbird at 541-686-0921 ext. 105 from 8am to 4pm PST Monday through Friday.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Hummingbird Wholesale has taken immediate action to recall the affected Organic Chocolate Hazelnut Butter in order to ensure the safety of its consumers.

Hummingbird Wholesale is dedicated to providing the highest quality organic and raw products, and the safety of our customers is our number one priority.

ESS Food Recalls Pork Products Produced Without Benefit of Import Inspection

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USDA-RECALL-1WASHINGTON – ESS Food, a Danish establishment, is recalling approximately 50,904 pounds of pork belly product produced in Poland that was not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The boneless pork belly was produced on various dates from March 3, 2014 to April 11, 2014. The following product is subject to recall:

Approximately 40-lb. boxes containing 4-5 pieces of “PINI POLONA PORK BELLY BONELESS”

The products subject to recall bear the establishment number “10023802” inside the Polish mark of inspection. The products were shipped to a distributor in Texas and a processing facility in Iowa.

The problem was discovered during routine surveillance of storage facilities when an FSIS investigator observed that the products lacked USDA import inspection marks.

This is a Class I Recall which indicates a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Consumers or Media with questions about the recall can contact Michael Stentebjerg, Area Manager, at (404) 254-8510.

California Firm Recalls Beef Products Produced Without Benefit of Import Inspection

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chicken-1WASHINGTON – ATM International USA, Inc., a Torrance, Calif. establishment, is recalling approximately 1,999 pounds of boneless beef products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The boneless beef products were imported from Japan on various dates between Oct. 9, 2014 – Jan. 15, 2015, and labeled in Japanese only.

  • Various weights and cuts of vacuum packed chilled boneless beef.

The vacuum packaging bears the Japanese translation for the following cuts:

  • Tender loin
  • Strip loin
  • Ribeye
  • Chuck Roll
  • Top Sirloin Butt
  • Chuck Ribs
  • Bottom Round
  • Top Round
  • Clod
  • Brisket
  • Short Plate
  • Short Rib
  • Knuckle

The above products would have been shipped either inside of a cardboard box with the Japanese establishment number “M2” and a box marking of “MZA-TN41”, “MZA-TN28” or “MZA-TN1” or inside of a Styrofoam box bearing the establishment number “EST. 27510” inside the USDA mark of inspection. These products were shipped to distributors and retail locations in Arizona, California, and Washington.

The problem was discovered during routine review of product tracking records.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Tuffy’s Pet Foods, Inc. Issues Voluntary Recall Nutrisca Dry Dog Food

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ucm434026PERHAM, MN – Tuffy’s Pet Foods, Inc. of Perham, MN is voluntarily recalling specific lots of 4 lb. bags of Nutrisca Chicken and Chick Pea Recipe Dry Dog Food because they have the potential to be contaminated with Salmonella. Tuffy’s manufactured the product for Nutrisca.

The recalled product was distributed in the 4 lb. bags nationwide to distributors, brokers, retail stores, and internet retailers. The recalled product is limited to Nutrisca Chicken and Chick Pea Recipe Dry Dog Food in 4 lb. bag sizes, bearing UPC Code “8 84244 12495 7” (found on lower back of the bag). Products included in the recall are identified by the below first 5 digits of the Lot Code (found on upper back of the bag) and “Best by Dates” (found on upper back of the bag). No other bag sizes or other Nutrisca dog food, cat food, biscuits/treats, supplements or other products, are affected by this announcement.

First five digits of Lot Codes:
4G29P, 4G31P, 4H01P, 4H04P, 4H05P, 4H06P

Best By Dates:
Jul 28 16, Jul 30 16, Jul 31 16, Aug 03 16, Aug 04 16, Aug 05 16

The recall was initiated after a routine sampling program by the Ohio Department of Agriculture revealed the presence of Salmonella in one 4 lb. bag of product. The company is coordinating this voluntary recall with the FDA, and is issuing the recall action out of an abundance of caution.

Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. 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. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers. Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. No Salmonella-related illnesses in people or animals have been reported to date in association with these products.

Consumers who purchased the 4 lb. bags of the dry dog food product subject to the voluntary recall (as identified above) should stop using the product, discard it in a safe manner (example, a securely covered trash receptacle), and contact Nutrisca at the number below for further information.

For consumer information or questions regarding this voluntary recall, please contact Nutrisca at 1-888-559-8833.

Pet International Inc. Recalls 6” Beef Trachea Pet Treat

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ucm433999Pet International of Miami, Florida is recalling 1500 units of 6” Beef Trachea Pet Treat because it has the potential to be contaminated with Salmonella. Salmonella can affect animals (i.e. dogs) eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

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. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Dogs with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets (i.e. dogs) will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your dog has consumed the recalled product and has these symptoms, please contact your veterinarian.

The 6” Beef Trachea Pet Treat was distributed to retail stores in the following Cities: Conifer, and Lakewood in Colorado.

If you have this product, use gloves and put in a double bag and throw it away as soon as possible. Do not touch the product in any way, and if you do, it’s recommended you must wash your hands immediately with an antibacterial soap.

The potentially affected product will pertain to a particular lot number, and are specific to a particular size of the pouch it’s sold in. Anyone having these products should verify the following:

Brand: Buster’s Natural Pet Supply,
Lot Code: 8501450,
Size: 6” Beef Trachea/ 12 Pack Plastic Pouch,
UPC Code: 8501450

No illnesses have been reported to date. We are still warning consumers that if any of the above information is on the package you have, do not feed it to any animals at all. It may be hazardous and should be disposed of immediately.

The recall was as the result of a routine sampling program by the Colorado Department of Agriculture and analyzed by FDA, obtained from Buster’s Natural Pet Supply in Conifer, CO. and found to be positive for Salmonella. The product sampled had a Buster’s Label on it, but was manufactured by Pet International. Buster’s Natural Pet Supply recalled the entire product from the two stores that the distributor sells it. The Pet International Inc. continues their investigation as to what caused the problem.

Consumers who have purchased 6” Beef Trachea with Buster’s Natural Pet Supply Label on it and are wishing to be refunded because of the recall, can take the product back to where bought it from, with receipt. A special form will be provided to be filled out as well. Both the form and the receipt are needed for the refund.

Consumers with any questions about the recall product may contact the company at by phone at (305) 591-3338 Monday through Friday 9:00am too 5:00pm EST or via e-mail at sergioh@petint.com.

Hospira Issues a Voluntary Global Recall of Multiple Lots of Ketorolac Tromethamine Injection

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Hospira_logoLAKE FOREST, Ill. — Hospira, Inc., (NYSE: HSP) has announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials. The particulate was identified as calcium-ketorolac crystals. Multiple lots are impacted by this recall; refer to the addendum for product list and lot information.

If particulates are not observed prior to administration, intramuscular (IM) or intravenous (IV) administration theoretically could result in localized inflammation, allergic reaction, granuloma formation or microembolic effects (IV only). However, there is no evidence indicating that IM or IV injection of inert particles results in harm to patients when only a small amount over a limited period of time is administered as is the case with ketorolac. Delay of therapy may occur due to particulates blocking the infusion of solution or due to observation of particulates at the point of care. However, this delay is likely to be of negligible clinical significance as this medication is administered by a health care provider and remediation is readily available.

The lots were distributed from February 2013 to December 2014 in the United States and from January 2014 to July 2014 in Singapore. Hospira has not received reports of any adverse events associated with this issue for these lots to date. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Anyone with an existing inventory of the recalled lots should stop use and distribution, and quarantine the product immediately. This recall is being carried out to the medical facility/retail level. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. Hospira has notified its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-888-345-4680 between the hours of 8am to 5pm ET, Monday through Friday. Customers outside the United States should work with their local Hospira offices to return the product per the local recall notification.

For clinical inquiries, please contact Hospira using the information provided below.

Hospira Contact Contact Information Areas of Support
Hospira Global Complaint Management 1-800-441-4100 (8am-5pm CT, M-F) (ProductComplaintsPP@hospira.com) To report adverse events
or product complaints
Hospira Medical Communications 1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week) Medical inquiries

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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Detox Transforms Health and Nutrition Issues Voluntary Nationwide Recall of Dietary Supplements

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dextrol-recallDetox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.

Product Name Bottle Color Label # Capsules UPC Lot Expiration
EDGE Amplified Weight Release White Purple label 60 852175004174 ALL
iNDiGO White Dark blue label 60 852175004044 000034 4/10/2017
AMPD Gold Bee Pollen White Black label 60 852175004181 ALL
BtRim Max White Dark Red label 60 852175004068 00002 4/27/2017
iNSANE Bee Pollen White Bright Red label 60 852175004082 0000:02 6/20/2017

FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended. Fluoxetine is an SSRI with potentially life-threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine-containing dietary supplement product. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.

The products were distributed nationwide via the internet and retail stores. No illnesses have been reported to date with the use of these products.

Detox Transforms has ceased distribution of the products as the company is working in close cooperation with the U.S. Food and Drug Administration (FDA) to fully resolve this issue. Detox Transforms is notifying its distributors and customers by email, telephone, and mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.

Consumers with questions regarding this recall may contact Detox Transforms at 877-404-7873 or 919-341-9050 between the hours of 10am – 6pm (EST), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with these of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

See’s Candies, Inc. Issues alert on Red Heart with Assorted Chocolates

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ucm433410SAN FRANCISCO — See’s Company of San Francisco is recalling all 8 oz Classic Red Hearts with Assorted Chocolates with bar code 737666091201 and stamped date L.A.N. 048/15 because it contains undeclared tree nuts. People who have an allergy or severe sensitivity to tree nuts (e.g.: almonds, walnuts, pecans, coconut) run the risk of serious or life-threatening allergic reaction if they consume these products.

Product was distributed nationwide through See’s Candies Retail Stores and Mail Order (Web/Phone/Catalog). The product is sold packaged at the stores in 8oz Red Heart boxes. No illnesses have been reported to date. The product UPC is: 737666091201.ucm433411

The recall was initiated after a retail store discovered a red heart with the incorrectly labeled base mixed in with properly labeled bases.

Consumers who have purchased Sees’ Candies Classic Red Hearts with Assorted Chocolates with bar code 737666091201 and lot L.A.N.048/15 and are sensitive to tree nuts are urged to return the hearts to the place of purchase for a full refund or exchange. Consumers with questions may contact the company at 1-800-789-7337 (Monday thru Friday, 8:30am to 4:30pm PDT).

J.J. Fuds, Inc. Issues Recall of Pet Food Because of Possible Health Risk

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jdfudsValparaiso, IN – J.J. Fuds in Valparaiso, IN is recalling a select lot and product of J.J. Fuds Chicken Tender Chunks Pet Food because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Animals’ ill with Listeria will display symptoms similar to the ones listed above for humans. People who have concerns about whether their pet has Listeria should contact their veterinarian.

The recalled product was distributed regionally in Minnesota, Wisconsin, Michigan, Indiana and Illinois to wholesale and retail customers. The product can be identified by the batch ID code (manufactured date) and UPC code printed on the back of the individual plastic bag or on the master case label. This product is a frozen raw poultry product (see Safe Handling Instructions on package) and has a shelf life of one year if kept frozen.

The recalled product is as follows:
J. J. Fuds Premium Natural Blends, Chicken Tender Chunks
All 5 lb. bags with:
Product UPC Number: 654592-345935
Manufacture/Lot Code Date: 5/5/14

The recall was a result of a routine sampling program by the Michigan Department of Agriculture and Rural Development resulting in a positive test for Listeria monocytogenes. The company has not received any reports of dogs experiencing nausea and diarrhea that may be associated with these specific products. The company has received no reports of human illness as a result of these products.

J.J. Fuds, Inc. will immediately start working with distributors and retailers to properly dispose of any affected product left on freezer shelves. The company will also be working with distributors and retailers to recall this product from pet owners to ensure the proper disposal of any affected product that has been purchased.

J.J.Fuds is issuing this action out of an abundance of caution and sincerely regrets any inconvenience to pet owners as a result of this announcement.

The recalled product should not be sold or fed to pets. Pet owners who have the affected product at home should return to retailer for a refund and proper disposal.

For further information or questions regarding this recall, please contact us at jjfuds.com or by phone at 888-435-5873 Monday-Friday 8AM-4PM CST.

Cox Veterinary Laboratory, Inc. Issues Voluntary Recall of “Gastroade Xtra”

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ucm431431

Chester, SC — Cox Veterinary Laboratory, Inc. is voluntarily recalling the lots of Gastroade Xtra identified below down to the consumer level
distributed nationwide. Gastroade Xtra was previously marketed by Cox Veterinary Laboratory as an OTC drug for use in horses, and contains Omeprazole. This recall has been initiated due to information from the FDA that Gastroade Xtra must have an approved new animal drug
application to be legally marketed in the United States. Gastroade Xtra is not approved by the FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration. As a consequence, Cox Veterinary Laboratory has ceased all production and sales of Gastroade Xtra and is recalling the product..

Because the FDA has not approved Gastroade Xtra, the safety and efficacy of the product has not yet been established. To date, however, there have been no reported adverse events associated with the use of Gastroade Xtra.

Gastroade Xtra is labeled for the care of gastric ulcers in horses. Gastroade Xtra is a paste that is packaged in a 32 ml tube bearing the name Gastroade Xtra, Omeprazole 2.28g.

Aided with the information provided by the FDA, Cox Veterinary Laboratory is notifying its
distributors and customers by a letter sent certified mail directly and through this press release of this voluntary recall. Cox Veterinary Laboratory will arrange for a return of all recalled product. Consumers and distributors that have unused Gastroade Xtra should stop using this product immediately and contact Cox Veterinary Laboratory to arrange for the return of the product.

Horse owners, caretakers and veterinarians should report to the FDA any adverse events,
including ineffectiveness, in horses that received unapproved omeprazole products. Information on reporting adverse events for approved or unapproved animal drugs can be found at: http://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm. Complaints about approved and unapproved animal drug products can be reported by calling a consumer complaint coordinator, within your FDA District Office or by filing a Veterinary Adverse Drug Reaction report.

Affected lots include Batch 0052 (UPC 091037382986) manufactured 5/29/2014.

Questions regarding this voluntary recall should be addressed to Jeanne Buffington by email at jeanne@coxvetlab.com from Monday to Friday, 10 am to 4pm, EST.

Consumers should contact their veterinary healthcare provider if they have experienced any problems that may be related to the use of this drug product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.