Grande Produce Issues Voluntary Recall of Limited Quantity of Papaya “Caribeña” Due to Potential Health Risk

Posted by jbushland on

Summary

Company Announcement Date:
July 26, 2017
FDA Publish Date:
May 02, 2019
Product Type:
Food & Beverages
Juice
Reason for Announcement:
Salmonella
Company Name:
Grande Produce
Brand Name:
Caribeña
Product Description:
Papaya Maradol

Company Announcement

Salmonella is an organism that 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, nausea, vomiting and abdominal pain.

Grande Produce has announced a voluntary recall of a limited quantity of Papaya Maradol (with the brand name Caribeña labeled on cartons) distributed during the dates of July 10 and July 19 due to a potential health risk from Salmonella.

According to Grande Produce, a Maryland distribution center where the papayas were delivered has already notified retail customers to remove the recalled papayas from inventories, store shelves and the stream of commerce.  Recall effectiveness checks are already underway by Grande Produce.

The only papayas subject to the recall carry a “Caribeña” brand label on cartons and were shipped during the dates of July 10 to July 19.  No other papayas or fresh produce distributed by Grande Produce are subject to the recall.

Grande Produce has ceased importation of papayas from the grower and is taking all precautionary measures to ensure the safety of its imported produce.  The company is also coordinating closely with the U.S. Food and Drug Administration and other regulatory agencies in their investigations and will provide any assistance possible.

Environmental microbial testing conducted by Grande Produce of its facilities has been negative for the Salmonella organism to-date.   Specific sources of what health officials now believe may be two separate Salmonella outbreaks have not yet been determined.  Of the 47 cases reported nationally, five illnesses are currently reported in the State of Maryland where Grande Produce distributed product. (more…)

Fred Meyer Stores Issues Allergy Alert on Fred Meyer 100% Whole Wheat Bread due to Undeclared Milk

Posted by jbushland on

Summary

Company Announcement Date:
February 07, 2017
FDA Publish Date:
May 02, 2019
Product Type:
Food & Beverages
Bakery Product/Mix
Reason for Announcement:
Company Name:
Fred Meyer Stores
Brand Name:
Fred Meyer
Product Description:
100% Whole Wheat Bread

Company Announcement

Fred Meyer Stores has recalled the 16 oz  Fred Meyer 100% Whole Wheat Bread sold in its retail stores because the product may contain nonfat dry milk not listed on the label.

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.

There have been no reports of illness to date. (more…)

Lipari Foods Issues Voluntary Recall of Various Bulk and Retail Cheese Products Due to Possible Health Risk

Posted by jbushland on

Summary

Company Announcement Date:
February 28, 2017
FDA Publish Date:
May 02, 2019
Product Type:
Food & Beverages
Cheese/Cheese Product
Reason for Announcement:
potential contamination of Listeria monocytogenes
Company Name:
Lipari Foods
Brand Name:
Lipari Old Tyme, Copperwood
Product Description:
Cheeses

Company Announcement

Lipari Foods, LLC has issued a voluntary recall of various bulk and retail cheeses manufactured by Deutsch Kase Haus due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is 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.

The products were distributed to food service and retail stores throughout Illinois, Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia.

Products were distributed under the following brand names: Copperwood and Lipari Old Tyme

The affected products can be identified by:

Brand Product Lipari
Product #		 Weight Sell By
Date		 UPC
Copperwood Colby Jack Mini Horn 359886 4/6# 8/7/17
8/15/17		 Sliced at deli counter no UPC and chunked with no bar code
Copperwood Pepper Jack Mini
Horn		 359880 4/6# 5/28/17 thru
10/24/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Colby Mini Horn 119536 2/6# 5/28/17 thru
10/24/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Colby Jack Longhorn 119636 2/14.5# 5/28/17 thru
10/24/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Colby Longhorn 119736 2/15.0# 5/28/17 thru
10/24/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Pepper Jack Mini
Horn		 119836 2/6# 5/28/17 thru
10/24/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Firecracker Jack Mini
Horn		 249203 2/6# 5/28/17 thru
10/24/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Swiss Cheese 126000 2/8# AVG 7/4/17
7/10/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Colby Jack Mini Horn 119436 2/6# 8/7/17
8/15/17		 Sliced at deli counter no UPC and chunked with no bar code
Lipari Old Tyme Colby Jack Cheese 185581 12/8 OZ 2/28/17 thru
8/14/17		 094776102211
Lipari Old Tyme Colby Cheese 185547 12/8 OZ 2/28/17 thru
8/14/17		 094776102273
Lipari Old Tyme Pepper Jack Cheese 185428 12/8 OZ 2/28/17 thru
8/14/17		 094776102303
Lipari Old Tyme Hot Pepper Cheese 185615 12/8 OZ 6/10/17 094776102280
Lipari Old Tyme Muenster Cheese 185496 12/8 OZ 6/4/17 094776102242

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

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Posted by jbushland on

Summary

Company Announcement Date:
September 28, 2018
FDA Publish Date:
May 02, 2019
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Company Name:
Endo Pharmaceuticals
Brand Name:
Endo Pharmaceuticals
Product Description:
Robaxin® (methocarbamol tablets, USP) 750mg Tablets

FDA Announcement

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” (see picture below for location of incorrect text).

Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. (more…)

Life Rising Corporation Recalls Chinese Herbal Supplements Because of Possible Health Risk

Posted by jbushland on

Summary

Company Announcement Date:
May 02, 2019
FDA Publish Date:
May 02, 2019
Product Type:
Dietary Supplements
Nutritional Supplement
Reason for Announcement:
Lead
Company Name:
Life Rising Corporation
Brand Name:
Life Rising, HoliCare
Product Description:
Dietary supplements

Company Announcement

Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead. According to FDA instruction, lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing.

The recalled products were mostly sold locally in Chicago area at HoliCare clinics and a limited quantity were also distributed through mail orders.

The recall includes all products purchased before May 2, 2019 of the Life Rising Holder-W Holder Warmer capsules and Life Rising NECK-ND Neck Clear capsules and lot number T81171040 of the HoliCare Metabolism Cleansing (MET-CLS) tablets. The Life Rising Holder-W Holder Warmer capsules are sold in a bottle with 54 capsules, the Life Rising NECK-ND Neck Clear capsules are sold in a bottle with 54 capsules, and the HoliCare Metabolism Cleansing (MET-CLS) tablets are sold in a bottle with 60 tablets, marked with lot # T81171040 on the bottom.

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

Taylor Farms Retail, Inc. Recalls Coleslaw Kits Due To Undeclared Milk Allergen

Posted by jbushland on

Summary

Company Announcement Date:
August 07, 2017
FDA Publish Date:
May 02, 2019
Product Type:
Food & Beverages
Prepared Food
Reason for Announcement:
Company Name:
Taylor Farms Retail, Inc.
Brand Name:
Taylor Farms
Product Description:
Coleslaw Kits

Company Announcement

Taylor Farms Retail, Inc. in Salinas is conducting a limited recall of 293 cases of Taylor Farms Creamy Homestyle Coleslaw Kits due to an undeclared milk allergen.  Milk is an ingredient in the dressing packet included in the salad kit.  This recall is limited to one production day from a single location which distributes to Raley’s in California and Savemart in California. The recall did not apply to any other Taylor Farms products.

Taylor Farms took this action proactively because people who are sensitive or have allergies to milk could be at risk of an adverse reaction if they consume this product. The undeclared allergen was discovered through a quality check.  At this time no reports of adverse reactions due to consumption of this product have been reported. Anyone concerned about a reaction should contact a healthcare provider. (more…)

Biohealth Nutrition Announces the Recall of Precision Blend Cookies and Cream Product for Undeclared Allergen

Posted by jbushland on

Summary

Company Announcement Date:
July 07, 2017
FDA Publish Date:
May 02, 2019
Product Type:
Food & Beverages
Snack Food Item
Reason for Announcement:
Company Name:
Biohealth Nutrition
Brand Name:
Biohealth
Product Description:
Precision Blend Time Release Protein Cookies and Cream

Company Announcement

Biohealth Nutrition of San Dimas, CA is recalling Precision Blend Cookies & Cream because product labels failed to declare the food allergen, wheat.

People who have an allergy or severe sensitivity to wheat run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume products containing allergens.

Precision Blend Cookies & Cream comes in 2 Lb. and 4 Lb. white plastic canisters with blue lettering and an image of two dark cookies filled with cream in the bottom front panel.

Biohealth Nutrition immediately segregated its entire inventory of Precision Blend Cookies & Cream product and is notifying consumers and customers not to consume them. Biohealth Nutrition wants to ensure its products are safe. Consequently, in addition to its ongoing cooperation with the California Department of Public Health, Biohealth nutrition is voluntarily recalling all Precision Blend Cookies & Cream products from its customers. Consumers in possession of these products should not eat them, rather product should be returned to the place of purchase. (more…)

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance

Posted by jbushland on

Summary

Company Announcement Date:
April 30, 2019
FDA Publish Date:
April 30, 2019
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Lack of Sterility
Company Name:
Sagent Pharmaceuticals
Brand Name:
Sagent Pharmaceuticals
Product Description:
Ketorolac Tromethamine Injection

Company Announcement

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death). The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue. (more…)

Licata Enterprises Asks For Volunary Recall of Multiple Vitamin Because of A Possible Fish Allergen Health Risk

Posted by jbushland on

Summary

Company Announcement Date:
February 14, 2017
FDA Publish Date:
April 29, 2019
Product Type:
Dietary Supplements
Vitamins
Reason for Announcement:
Company Name:
Licata Enterprises
Brand Name:
The Supreme One / Theravits
Product Description:
Vitamins

Company Announcement

Licata Enterprises of Huntington Beach, California is recalling its The Supreme One / Theravits 100 multiple vitamin (all lots) due to the discovery of a confusing labeling issue which could cause cause individuals allergic to fish oils to ingest the product in error. The product contains Vitamin A (partially from fish liver oil) which is clearly stated in the Supplement Facts portion of the label; however, another part of some labels also incorrectly state “… contains no common allergens” leading some with fish allergies to believe the product is safe for them. Further, the separate Allergen statement contains fish is missing. And, on some labels the following ingredients were missing: Molybdenum, Pancreatin, Diastase, Papain, Ox Bile, Vanadium, Silicon, Boron, and Bromelain.

The above products were distributed primarily Southern California, Ohio and Pennsylavnia through health food stores, but also in Wyoming, Virginia, Utah, Idaho, Washington, Oregon and Texas.

The Supreme One and Theravits 100 product is sold under the brand names of Nature’s Concept, VP Discount, Clark’s Nutrition, Hsu & Co, Spatz, Weber Health Foods, Harvest Natural Foods, Nature’s Nutrition, Vita Sun, Good Health, Kraski’s, Lynden Nutrition, Seaside Health Foods, and Vita-Vista. The product is packaged in amber or white plastic bottles with the product Code Number of 680 or 078 and the lot numbers 680xxxx or 078xxxx. NO illnesses have been reported to date. (more…)

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

Posted by jbushland on

Summary

Company Announcement Date:
October 17, 2018
FDA Publish Date:
April 29, 2019
Product Type:
Food & Beverages
Candy/Gum (without chocolate)
Reason for Announcement:
Company Name:
New Nan Fong
Brand Name:
Source Day Natural Treasures
Product Description:
Liquorice Slice

Company Announcement

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.

The product comes in a 16 oz (454g) plastic package, no expiration date, no UPC code. It is a product of China. The recalled Source Day Natural Treasures Dried Liquorice Slice was distributed in New York City.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by the New York State Food Laboratory personnel revealed the presence of sulfite allergens in packages of Source Day Natural Treasures Dried Liquorice Slice which did not declare sulfites as an ingredient on the label.

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