Category Archives: FDA

USA – Lipari Foods Issues Recall of Bulk Chicken Salads and Chicken Salad Sandwiches Due to Potential Contamination of Listeria Monocytogenes

FDA

Company Announcement

Lipari Foods has issued a voluntary recall of Lipari Old Tyme Bulk Chicken Salad, Lipari Old Tyme Bulk Cranberry Almond Chicken Salad, Premo Chicken Salad Wedge Sandwiches, Fresh Grab Chicken Salad Wedge Sandwiches, and Premo Signature Cranberry Almond Chicken Salad on Croissant due to potential contamination of Listeria monocytogenes.

The product was distributed exclusively by Lipari Foods in Warren, Michigan to food service and retail stores throughout Florida, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin.

Label, Lipari Old Tyme Chicken Salad

USA – E.A. Sween Announces Product Recalls Due to Possible Listeria Contamination

FDA

Company Announcement

E.A. Sween Company announced the recall of multiple products due to possible contamination of 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.

Tip Top Poultry, Inc., initiated a recall and is an ingredient provider to two of E.A. Sween’s suppliers, The Suter Company, Inc. that provides chicken salad products and Baja Foods LLC that provides burritos, to the company. To date, we have not received any reported illnesses related to this organism.

Retailers have been instructed to remove affected products from store shelves and inventory immediately. Customer partners with questions are asked to call our Customer Service hotline at 1-800-328-8184 and select #6 for information and refund instructions.

Affected product could have been delivered in the Continental U.S., Hawaii and Guam through convenience stores and grocery and mass retail outlets. Consumers may return the affected product to the store where it was purchased for a full refund or exchange. If the product has been consumed, please call our Consumer Hotline, Monday through Friday from 8:00 a.m. to 4:00 p.m. CST at 1-800-328-8184 and select #5.

E.A. Sween is taking this action out of caution for the safety of our consumers.

Label, Deli Express Chicken Salad Wedge

USA – Dorset Cheese Voluntarily Recalled by North Atlantic and Northeast Whole Foods Market Stores Due to Possible Health Risk – Listeria monocytogenes

FDA

Company Announcement

In response to a recall from Consider Bardwell Farm, Whole Foods Market stores in the Northeast and North Atlantic regions are voluntarily recalling Dorset cheese because of a potential contamination of Listeria monocytogenes.

Listeria monocytogenesis an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women 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, stillbirths and fetal infection among pregnant women.

The affected product was sold at Whole Foods Market stores in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York and Rhode Island. The affected product was cut and wrapped in plastic with a Whole Foods Market scale label, identifiable by PLU code 97776 with sell-by dates through 10/30/2019.

No illnesses have been reported to date.

Customers who purchased this product at Whole Foods Market can bring a valid receipt into stores for a full refund. Consumers with additional questions can call 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 p.m. CST, Monday through Friday, or 8:00 a.m. and 6:00 p.m. Saturday through Sunday.


Company Contact Information

Consumers:
 1-844-936-8255
Media:
Olivia Petersen
 Olivia.Petersen@wholefoods.com

Product Photos

USA – Outbreak Investigation of Cyclospora Illnesses Linked to Imported Fresh Basil, July 2019

FDA 220px-Cyclospora_cayetanensis_stained

September 30, 2019

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), and state and local partners, have been investigating a multistate outbreak of Cyclospora illnesses linked to fresh basil exported by Siga Logistics de RL de CV located in Morelos, Mexico.

FDA’s traceback investigation confirmed that the fresh basil available at points of sale where some consumers became ill was exported to the United States by Siga Logistics de RL de CV located in Morelos, Mexico. FDA continues its investigational activities.

Siga Logistics de RL de CV recalled potentially affected basil on July 24, 2019. The firm has been cooperative with the investigation, ceasing production and distribution of the product.

According to the CDC, this outbreak appears to be over.

USA – Consider Bardwell Farm Recalls Dorset, Slyboro, and Experience Because of Possible Health Risk – Listeria monocytogenes

FDA Image of cheese and label: Consider Bardwell Farms Slyboro Goat Cheese

Company Announcement

Consider Bardwell Farm, LLC of West Pawlet, Vermont, is recalling the following cheeses:

Product Name Unit Size Comments Product Code Product Dates
Slyboro 2 pound wheel Units per case: 2
Case dimensions: 12”x 6”x 4”
Gross case weight: 4 lb
Pallet boxes per layer (TI): 24
Pallet number of tiers (HI): 12
Cases per pallet: 288
All in your possession 4/28/2019 until present
Dorset 2.5 pound wheel Units per case: 4
Case dimensions: 8”x 8”x10”
Gross case weight: 10 lb
Pallet boxes per layer (TI): 30
Pallet number of tiers (HI): 8
Cases per pallet: 240
All in your possession 4/28/2019 until present
Experience Three quarters pound square Units per case: 8
Case dimensions: 12”x 6”x 4”
Gross case weight: 4 lb
Pallet boxes per layer (TI): 24
Pallet number of tiers (HI): 12
Cases per pallet: 288
All in your possession 4/28/2019 until present

These products have been distributed in: CA, MA, NY, TX, VT.

These products may 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. Healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.

No illnesses have been reported to date in connection with these products. This is a voluntary and precautionary recall initiated by Consider Bardwell Farm. The contamination was discovered by routine testing of finished products and the manufacturing environment.

USA – Gramco, Inc. Recalls Hog Grower Pellets because of Elevated Vomitoxin Levels

FDA

Company Announcement

Gramco, Inc. of Springville, New York is recalling bags of Hog Grower Pellets because it contains levels of vomitoxin (a mycotoxin) that could be harmful to swine growth and potentially fatal to young swine.

This product has a lot number of 47284 and it was produced on July 8, 2019. The FDA tested a product sample and has determined that the levels of vomitoxin in this lot exceeds its guidelines for swine feed. The FDA notified us of the results and that they were considered too high for swine feed and we took action as soon we learned of it. This product was sold to a retailer in the Bradford, Pa. area and other than that, it was sold to end-users who either had it delivered to their farms for use or picked it up at the plant for use at home. At this point, we have not had any complaints of animal refusal for intake, nor have we had any complaints of animal health issues or worse.

The product in question all went into 50 pound bags that would have the Gramco, Inc. logo on them.

Vomitoxin (Deoxynivalenol) is known to cause vomiting (emesis), ulcer in the mouth, feed refusal, and decreased body weight gain in swine of all age classes. Swine exposure to elevated levels of vomitoxin in feed for extended period may lead to intestinal and liver damages, kidney failure, immune system failure, and eventually death.

Working with the FDA, we are instituting a revised testing program to help prevent this in the future. We look forward to working with you and we apologize for any inconveniences brought on by this incident.

If you have any of these bags left please do not feed them and please contact John Wallace at 716-592-2845 between the hours of 7 a.m. and 5 p.m. Monday thru Friday.

Here is a copy of the tag that would be on the bags with a rubber date stamp of July 8th, 2019 near the top.


Company Contact Information

Consumers:
John Wallace
 716-592-2845

Product Photos

USA – Euphoria Fancy Food Inc. Recalls “Capitan K Salmon Fillet” Due to Possible Health Risk – Listeria monocytogenes

FDA

Company Announcement

Euphoria Fancy Food Inc of Brooklyn, NY is recalling its 7.05 oz packages of “CAPITAN K” salmon slightly salted pieces because they may be contaminated with Listeria monocytogenesan organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy persons 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.

The recalled “ CAPITAN K ” salmon slightly salted pieces were distributed nationwide in retail stores and through mail orders. The product comes in 7.05 oz, vacuum package marked with container code of 070519 and with a best by date of 01/30/20. The product UPC code is 607059000362.

No illnesses have been reported to date and connection with this problem.

The contamination was discovered after sampling by New York State Department of Agriculture and Market Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of Listeria monocytogenesin some 7.05 oz vacuum packages of “CAPITAN K” salmon slightly salted pieces.

Consumers who have purchased 7.05 oz vacuum packages of “CAPITAN K” salmon slightly salted pieces are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-768-3400.


Company Contact Information

Consumers:
Michael Briskin
 718-768-3400

Product Photos

USA – Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL due to Microbial Contamination

FDA

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Microbial Contamination
Company Name:
Plastikon Healthcare
Brand Name:
Major Pharmaceuticals
Product Description:
Milk of Magnesia Oral Suspension 2400 mg/30 ml

Company Announcement

Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling Milk of Magnesia 2400 mg/30 mL Oral Suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon’s in-house microbiological specification for Total Aerobic Microbial Count.

This product is packaged for institutional use and is sold to clinics and hospitals, the patient population most likely to use the product are likely immunocompromised. Patients with compromised immune systems, such as patients in hospitals and nursing homes, have a higher probability of developing potentially life-threatening infections after taking a contaminated product. To date, Plastikon has not received any customer complaints or reports of adverse events related to this issue. Milk of Magnesia 2400 mg/ 30 mL is indicated for the occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.

Milk of Magnesia 2400 mg/ 30 mL Oral Suspension is privately labeled by Major Pharmaceuticals® and packaged in cartons as indicated below. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler), who may have shipped to clinics, hospitals and healthcare providers, in the United States, in August 2019.

Carton NDC Lot Number Expiration Date Strength Configuration/Count
0904-6846-73 19027D 2021 July 2400 mg/30 mL Carton containing 100 single dose cups (10 trays x 10 cups)
0904-6846-73 19027E 2021 July 2400 mg/30 mL Carton containing 100 single dose cups (10 trays x 10 cups)

Plastikon Healthcare places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product.

Anyone with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform healthcare professionals in your organization of this recall. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify these patients regarding the recall. For additional assistance, call Plastikon Healthcare at 785-330-7100 (Monday through Friday, 8 a.m. to 5 p.m. CST).

For clinical inquiries, please contact Plastikon Healthcare using the below information.

Contact Center Contact Information Area of Support
Plastikon Healthcare 816-721-3269 (24 hours a day 7 days per week) To report adverse events or product complaints

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product lots. Patients with the affected lots should return the product to their pharmacy or contact Plastikon Healthcare (785-330-7100) for instructions on how to return their product and obtain reimbursement for their cost. 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 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.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Milk of Magnesia label, top view

USA – FDA – Food Safety Reporting Portal

Safety Reporting

The Safety Reporting Portal

The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) and the National Institutes of Health (NIH).

Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America’s food supply, medicines, and other products that touch us all.

Parts of this website have been translated from English to Spanish. Pages that have been translated have an “En Espanol” link in the upper right part of the page. Click this link to see the page in Spanish (Espanol). Click “In English” to see the page in English. In the case of any discrepancy in meaning, the English version is considered official. Currently, report questions are only in English and reports should only be submitted in English. Thank you for using the FDA Safety Reporting Portal.

USA – Mountain Mel’s Essential Goods, LLC Recalls The Milk Lady’s Herbal Tea Blend, Peaceful Baby Herbal Tea Blend, and Diges-teas Herbal Tea Blend, Because of Possible Health Risk – Salmonella

FDA

Mountain Mel’s Essential Goods, LLC of Welches, OR is recalling The Milk Lady’s Tea with LOT # ML6271950, Peaceful Baby Herbal Tea with LOT # PB781950, and Diges-Teas Herbal Tea with LOT # DT7619100, 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 Salmonellacan result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The Milk Lady’s, Peaceful Baby, and Diges-Teas were distributed in Oregon and Washington through New Seasons Market, and nationwide through Azure Standard, Mountainmels.com and Amazon.com. The affected tea products were distributed by Mountain Mel’s Essential Goods June 27, 2019 and July 20, 2019.

The Milk Lady’s Herbal Tea Blend, UPC 7 99632 05658 4, is packaged in a tall thin tin container with 2 oz of tea per tin, with a purple label. The LOT# of the recalled batch is # ML6271950. The LOT# can be located on the bottom of the tin package. The Best By Date of the Milk Lady’s Tea is listed as 7/2021.

Peaceful Baby Herbal Tea Blend, UPC 7 99632 05656 0, is packaged in a tall thin tin container with 2 oz of tea per tin, with a blue label. The LOT# of the recalled batch is #PB781950. The LOT# can be located on the bottom of the tin package. The Best By Date of the Peaceful Baby Tea is listed as 7/2021.

Diges-Teas Herbal Tea Blend, UPC 7 99632 05665 2, is packaged in a tall thin tin container with 2 oz of tea per tin, with a brown label. The LOT# of the recalled batch is #DT7619100. The LOT# can be located on the bottom of the tin package. The Best By Date of the Diges-Teas Herbal Tea is listed as 7/2021.

No illnesses have been reported to date.

This recall was initiated because the herbal teas were made with the recalled fennel seed whole that was supplied and recalled by Mountain Rose Herbs in Oregon. Mountain Mel’s Essential Goods has ceased production and distribution of this product as of July 20, 2019.

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

Consumers who have purchased Mountain Mel’s The Milk Lady’s Tea with LOT # ML6271950, Peaceful Baby Herbal Tea with LOT # PB781950, and/or Diges-Teas Herbal Tea with LOT # DT7619100 are urged to take a photo of the product and lot label, email that to info@mountainmels.com for a full refund.

Consumers with further questions may contact Mountain Mel’s via email at info@mountainmels.com.