**Warning issued for raw milk cheese because of positive test results for Listeria

By News Desk on Nov 29, 2023 06:09 pm

The Pennsylvania Department of Agriculture warns that consumers should discard “Hilltop Meadow Farm” brand ’60 Day Aged Pepper Jack Raw Milk Cheese’ with sell by dates of Sept. 21 or earlier. Testing of this cheese confirmed the presence of Listeria monocytogenes bacteria. The Pepper Jack Raw Milk Cheese from Hilltop Meadow Farm, 153 martin Road, Pine Grove,… Continue Reading

** Argentina records hundreds of Trichinella cases

By News Desk on Nov 30, 2023 12:05 am

More than 650 potential Trichinella infections have been reported in an Argentinian province so far this year. Health officials in Buenos Aires recorded 651 suspected cases, of which 399 are confirmed, 14 are probable, and 212 remain under study. Seven trichinosis (or trichinellosis) outbreaks have occurred, six of them small, but one stretching through 12 municipalities…. Continue Reading

** FSA issues chocolate warning after reports of illness

By News Desk on Nov 29, 2023 12:04 am

The Food Standards Agency (FSA) has warned people not to eat Caligold chocolate following reports of illness. The 70 percent dark chocolate bars were sold at Mansfield Market in Nottinghamshire, England. FSA and other authorities are trying to find out whether the product has a wider distribution. Police referred the incident to the FSA…. Continue Reading

** Amos Miller exits federal court in 2023 as the third time is the charm

By Dan Flynn on Nov 30, 2023 12:06 am

Amish farmer Amos Miller is holding up his third agreement with the federal government. It means his appearances in federal court are over. USDA enforcement of federal food safety regulations has prevailed. Miller proved to be a difficult assignment for USDA’’s Food Safety and Inspection Service (FSIS), which first took civil action against Miller’s Organic… Continue Reading

** Wilcox Ice Cream Recalls Multiple Ice Cream Products Because of Possible Health Risk

Wilcox Ice Cream of East Arlington, VT is recalling all flavors of Wilcox brand ice cream, yogurt, and ice cream bars, as well as Leonardo’s brand gelato after being notified by the Vermont Department of Agriculture on 11/14/23 that one lot of the Super Premium Mint Chip manufactured that day may be contaminated with 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.

In addition to that flavor we are recalling ALL other products manufactured at our facility with during the same time period. This involves the following flavors, sizes, and best by dates: Wilcox Premium Product Line – All Flavors – All Sizes with Best By/Sell By dates of 9/14/24 to 11/14/24

** CF Dallas, LLC, in Coordination with Sofia Produce, LLC Dba Trufresh, Voluntarily Recalls Select Fresh-Cut Fruit Products Due to Possible Salmonella Contamination

CF Dallas, LLC is voluntarily recalling select fresh-cut products made from whole cantaloupe subject to a previously announced product recall initiated by Sofia Produce, LLC dba Trufresh due to potential Salmonella contamination. All CF Dallas fresh-cut fruit products associated with the recalled whole cantaloupe have expired, however consumers who have purchased these items and may have frozen them for later use are urged not to consume the products and to dispose of them immediately or return the items to their local store for a full refund.Salmonella is 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.

** November 8, 2023 – Maryland Heights, MO, SugarMDs, LLC is voluntarily recalling Lot: 22165-003 Advance Glucose Support Supplement in 60, 120 and 180 count bottles to the consumer level. FDA analysis has found the product to be tainted with glyburide and metformin. Glyburide and Metformin are active ingredients found in several FDA-approved prescription drugs used to treat type 2 diabetes. Products containing glyburide and metformin cannot be marketed as dietary supplements. Advanced Glucose Support Supplement is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement:
Glyburide may pose serious and potentially life-threatening risks to consumers because this ingredient may result in unsafe drops in blood sugar levels (hypoglycemia). Common symptoms of hypoglycemia include fast heartbeat, shaking, sweating, nervousness or anxiety, irritability or confusion, dizziness, drowsiness, headache and hunger. Hypoglycemia may quickly become severe, resulting in seizures, coma or death.

Metformin may pose a serious risk to consumers because this ingredient can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death if untreated. Symptoms of lactic acidosis include nausea, vomiting, fatigue, body aches, respiratory distress, abdominal pain and fast, deep breathing. Metformin may also cause hypoglycemia when taken together with other medications to lower blood sugar.

To date, SugarMDs LLC has not received any reports of adverse events related to this recall.

This tainted Advanced Glucose Support is marketed as a dietary supplement and is packaged in:

60 count bottle : UPC code 00195893927678 (UPC code located below the “Supplement Facts” panel)
120 count bottle: UPC code 00195893546978
180 count bottle: UPC code 00195893999576

An example product label can be found below:

The affected Advanced Glucose Support lots include the following:

Lot# 22165-003 EXP: 09/2024

The product was distributed Nationwide in the US -through internet sales via amazon.com External Link Disclaimer and sugarmds.com External Link Disclaimer.

SugarMDs LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase for a full refund.

Consumers with questions regarding this recall can contact SugarMDs LLC by 561-462-5053 or feedback@sugarmds.com Monday through Friday from 9 am – 5 pm Eastern Time. 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.

** Skyline Provisions, Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination

Skyline Provisions, Inc., a Harvey, Ill. establishment, is recalling approximately 5,620 pounds of raw ground beef products that may be contaminated with a foreign object, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

** FDA Warns Consumers Not to Purchase or Use Neptune’s Fix or Any Tianeptine Product Due to Serious Risks: FDA Safety Communication

FDA is warning consumers to not purchase or use any Neptune’s Fix products, or any other product with tianeptine — a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.

FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help.

Neptune Fix’s labels state the product contains tianeptine, but may contain other harmful ingredients not listed on the label. These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or other locations. FDA is testing these products and will provide more information as it becomes available. FDA also continues to warn consumers about risks of using tianeptine.

Read More

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

** November 17, 2023 – WHIPPANY, N.J., Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.

Risk Statement: Given that Vitrakvi® is indicated for the treatment of solid tumors that are NTRK gene fusion positive, it is expected that patients on Vitrakvi® may be immunocompromised. Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi® with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening. To date, Bayer has not received any adverse events related to this recall.

The impacted lot of Vitrakvi® is packaged in a 100mL glass bottle with NDC# 50419-392-01 and is identified with Lot# 2114228 and an expiration date of February 29, 2024. Lot# 2114228 was distributed to wholesale distributors and specialty pharmacies nationwide between January 3, 2023, and February 13, 2023.

Product bottle and carton label images and information on the lot number that falls under this recall is available at:

Vitrakvi Recall Lot # Photos 11.17.23.pdf (bayer.com)External Link Disclaimer

Bayer notified all distributors and pharmacies of this recall on November 8, 2023. Bayer has engaged Qualanex to manage the recall of the product down to the consumer level. Qualanex has notified Vitrakvi® distributors via a recall notification letter and will arrange for the return of the recalled lot from distributors, specialty pharmacies, and consumers. Consumers with general questions regarding this recall can contact Qualanex via e-mail at Recall@qualanex.com or toll free at 888-280-2043, Monday-Friday between the hours of 7 a.m. and 4 p.m. Central Standard Time.

Consumers who have the recalled Vitrakvi® product should immediately stop use of this particular lot of product and contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to Vitrakvi® Oral Solution 20 mg/mL.

Patients or prescribers who have questions regarding the recall can contact Bayer Medical Information Call Center at 888-842-2937, Monday-Friday between the hours of 8:30 a.m. and 8:00 p.m. Eastern Standard Time.

** HMC Farms Voluntarily Recalls Whole Peaches, Plums and Nectarines Sold at Retail Stores in 2022 and 2023 Because of Possible Health Risk

November 17, 2023 – The HMC Group Marketing, Inc., which does business as HMC Farms, is voluntarily recalling peaches, plums and nectarines sold in retail stores between May 1 and November 15, 2022 and between May 1 and November 15, 2023. The fruit is being recalled because it has the potential to be contaminated with Listeria monocytogenes, an organism that 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 recalled fruit was distributed nationwide and sold at retail stores as individual pieces of fruit bearing PLU stickers (see photos) or in consumer packaging (also shown in the attached photos) AND sold at retail between May 1 and November 15, 2022 and between May 1 and November 15, 2023.

** New infections from Listeria linked to fresh peaches, nectarines and plums

By Coral Beach on Nov 18, 2023 05:52 pm

A new outbreak of infections from Listeria has sparked a recall of whole, fresh peaches, plums and nectarines. The recall implicates 12 fresh fruits sold under at least three brands. The HMC Group Marketing Inc. company issued the recall for the fruit, which has been distributed nationwide. Click here to view packaging that can help… Continue Reading

** WanaBana Recalls WanaBana, Weis, and Schnucks Apple Cinnamon Fruit Purée Pouches & Cinnamon Apple Sauce Due to Elevated Lead Levels

For Immediate Release – November 9, 2023 – United States – WanaBana USA is voluntarily recalling all lots of WanaBana Apple Cinnamon Fruit Purée pouches due to reports of elevated levels of lead found in certain units of the product.

Pursuant to the FDA, lead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is important to lifelong good health. Lead exposure in children is often difficult to see. Most children have no obvious immediate symptoms. If you suspect that your child might have consumed this product, parents should talk to your child’s healthcare provider about getting a blood lead test. Lead poisoning can only be diagnosed through clinical testing. Although signs and symptoms of lead toxicity vary, short term exposure to lead could result in the following symptoms:

Headache
Abdominal pain/Colic
Vomiting

Anemia

** Sofia Produce, LLC DBA Trufresh Recalls Fresh Cantaloupe Because of Possible Health Risk Due to Salmonella

SOFIA PRODUCE, LLC, of Nogales, Arizona which does business under the name “Trufresh” (“Trufresh”) is recalling all sizes of fresh cantaloupes packaged in cardboard containers labeled with the “Malichita” label, sold under the following sales order numbers between October 16, 2023 and October 23, 2023 because they have the potential to be contaminated with Salmonella:Salmonella is 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.

** The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands.

Brand Name	Part Number	Description	UDI
CARDINAL	1020	100ML STERILE SALINE BOTTLE	(01)50192253044490
CARDINAL	1022	100ML STERILE SALINE BOTTLE	(01)50192253044506
CARDINAL	PT00103427	100ML STERILE SALINE BOTTLE	(01)50192253044506
CARDINAL	1024	100ML STERILE WATER BOTTLE	(01)50192253044513
CARDINAL	10000	100ML STERILE WATER BOTTLE	(01)50192253044520
CARDINAL	PT00103419	100ML STERILE WATER BOTTLE	(01)50192253044513
COVIDIEN	210SAL	STERILE WOUND SOLUTION	(01)10884521139756
COVIDIEN	90SAL	STERILE WOUND SOLUTION	(01)20884521140940
HALYARD OWENS MINOR	SS003	0.9% USP SODIUM CHLORIDE INJECTION	(01)20885632389778
HALYARD OWENS MINOR	SS005	0.9% USP SODIUM CHLORIDE INJECTION	(01)20885632389761
HALYARD OWENS MINOR	SS010	0.9% USP SODIUM CHLORIDE INJECTION	(01)20885632389754
HALYARD OWENS MINOR	49154	1000ML STERILE SALINE BOTTLE	(01)20885632395939
HALYARD OWENS MINOR	49150	1000ML STERILE WATER BOTTLE	(01)20885632395892
HALYARD OWENS MINOR	49155	100ML STERILE SALINE BOTTLE	(01)20885632395946
HALYARD OWENS MINOR	49151	100ML STERILE WATER BOTTLE	(01)20885632395908
HALYARD OWENS MINOR	SS010SFR	10ML SYRINGE STERILE	(01)20885632389846
HALYARD OWENS MINOR	49152	250ML STERILE SALINE BOTTLE	(01)20885632395915
HALYARD OWENS MINOR	49148	250ML STERILE WATER BOTTLE	(01)20885632395878
HALYARD OWENS MINOR	49153	500ML STERILE SALINE BOTTLE	(01)20885632395922
HALYARD OWENS MINOR	49149	500ML STERILE WATER BOTTLE	(01)20885632395885
IDEXX	98-09444-01	BOTTLE STERILE WATER 10 PACK	No UDI
MAC MEDICAL	9210	10ML FILL SYRINGE LABEL	20850020865042
MCKESSON	37-6281	1000ML STERILE SALINE BOTTLE	612479228399
MCKESSON	37-6291	1000ML STERILE WATER BOTTLE	612479228405
MCKESSON	37-6240	100ML STERILE SALINE BOTTLE	612479168565
MCKESSON	37-6250	100ML STERILE WATER BOTTLE	612479168572
MCKESSON	37-6220	120ML STERILE SALINE CUP	612479168558
MCKESSON	37-6210	120ML STERILE WATER CUP	612479168541
MCKESSON	37-6507	210ML SALINE WOUND FLUSH	612479133761
MCKESSON	37-6270	250ML STERILE SALINE BOTTLE	612479168596
MCKESSON	37-6260	250ML STERILE WATER BOTTLE	612479168589
MCKESSON	37-6280	500ML STERILE SALINE BOTTLE	612479180307
MCKESSON	37-6290	500ML STERILE WATER BOTTLE	612479180314
MCKESSON	37-6503	88.7ML SALINE WOUND FLUSH STERILE	612479228429
MEDICHOICE OWENS MINOR	SWF071	CAN STERILE SALINE SPRY MEDI 7.1 OZ	(01)50885632127043
MEDLINE	DYND1000MLS	1000ML STERILE SALINE BOTTLE	(01)208882776699466
MEDLINE	52011	100ML STERILE SALINE BOTTLE	Customer Kitted
MEDLINE	RDI30296	100ML STERILE SALINE BOTTLE	(01)40884389338248
MEDLINE	54380	100ML STERILE WATER BOTTLE	Customer Kitted
MEDLINE	RDI30295	100ML STERILE WATER BOTTLE	(01)40884389338231
MEDLINE	EMZ10091240	10ML IV FLUSH STERILE FIELD	(01)20363807109166
MEDLINE	DYND40540	110ML STERILE SALINE CUP	(01)40884389334233
MEDLINE	DYND40570	110ML STERILE WATER CUP	(01)40884389334226
MEDLINE	PCS1650	250ML STERILE SALINE BOTTLE	(01)40884389338262
MEDLINE	PCS1550	250ML STERILE WATER BOTTLE	(01)40080196427056
MEDLINE	DYND500MLS	500ML STERILE SALINE BOTTLE	(01)40884389118406
MEDLINE	DYND500MLW	500ML STERILE WATER BOTTLE	(01)40884389118390
MEDLINE	CURSALINE7	CAN SALINE STERILE SPRAY CURAD	40080196297970
NURSE ASSIST	6492775	100ML STERILE SALINE BOTTLE	B15064927754G
NURSE ASSIST	6492776	100ML STERILE WATER BOTTLE	B15064927764H

NURSE ASSIST	1010	10CC PREFILLED SYRINGES	+B15010104L
NURSE ASSIST	51638	10CC PREFILLED SYRINGES	+B150516384%
NURSE ASSIST	1210-BP	10ML IV FLUSH SYRINGE	+B1501210BP4G
NURSE ASSIST	6496723	30CC PREFILLED SYRINGE	B15064967234D
NURSE ASSIST	52333	30CC PREFILLED SYRINGES	+B150523334Z
NURSE ASSIST	1203-BP	3ML IV FLUSH SYRINGE	+B1501203BP4I
NURSE ASSIST	1205-BP	5ML IV FLUSH SYRINGE	+B150120BP4K
NURSE ASSIST	6496722	SYRINGE PREFILLED 10 ML	B15064967224C
NURSE ASSIST	1030	USP STERILE WATER SYRINGE	+B15010304N
NURSE ASSIST	1030A	USP STERILE WATER SYRINGE	+B1501030A4X
SOL	PFF001	0.9% SODIUM CHLORIDE IV FLUSH SYRINGE	(01)20810062438895
STERICARE	6281	1000ML STERILE SALINE BOTTLE	(01)10850421008843
STERICARE	6291	1000ML STERILE WATER BOTTLE	(01)10850421008799
STERICARE	6240	100ML STERILE SALINE BOTTLE	(01)10850421008812
STERICARE	6250	100ML STERILE WATER BOTTLE	(01)10850421008768
STERICARE	6220	120ML STERILE SALINE FOIL LID CUP	(01)10850421008874
STERICARE	6210	120ML STERILE WATER FIOL LID CUP	(01)10850421008867
STERICARE	6507	210ML SALINE WOUND FLUSH	(01)10850421008744
STERICARE	6270	250ML STERILE SALINE BOTTLE	(01)10850421008829
STERICARE	6260	250ML STERILE WATER BOTTLE	(01)10850421008775
STERICARE	5280	500ML STERILE SALINE BOTTLE	850421008907
STERICARE	6280	500ML STERILE SALINE BOTTLE	(01)10850421008836
STERICARE	5290	500ML STERILE WATER BOTTLE	850421008914
STERICARE	6290	500ML STERILE WATER BOTTLE	(01)10850421008782
STERICARE	6503	90ML USP SALINE WOULD FLUSH	(01)10850421008751
TRUDELL	T167007	CUP STERILE SALINE FOIL LID 120 ML	No UDI
TRUDELL	T167005	CUP STERILE WATER FOIL LID 120 ML	No UDI
VYAIRE	4873C	CUP STERILE SALINE FOIL LID 120 ML	Discontinued

On November 6, 2023, Nurse Assist, LLC announced a recall of the following water-based medical products because the products may not be sterile:

0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes);
Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes).

These products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire. The recalled products may be available as individual units or may be included as part of a kit.

Product information provided by the company, including Unique Device Identifier (UDI), is in the table below.

The recalled products have these expiration dates:

November 1, 2023 – September 18, 2025 (all products, except for 1030A)
November 1, 2023 – September 18, 2028 (part number 1030A)

Nov. 4, 2023** – Tyson Foods, Inc. a Berryville, Ark., establishment, is recalling approximately 29,819 pounds of fully cooked, breaded, shaped chicken patty product that may be contaminated with extraneous materials, specifically metal pieces, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen chicken patties were produced on September 5, 2023. The following product is subject to recall [view labels]:

29-oz. Plastic bag packages containing “Tyson FULLY COOKED FUN NUGGETS BREADED SHAPED CHICKEN PATTIES” with a Best If Used By date of SEP 04, 2024, and lot codes 2483BRV0207, 2483BRV0208, 2483BRV0209 and 2483BRV0210.

The product subject to recall bears establishment number “P-7211” located on the back on the package. The product was shipped to distributors in Alabama, California, Illinois, Kentucky, Michigan, Ohio, Tennessee, Virginia, and Wisconsin for further distribution to the retail level.

The problem was discovered after the firm notified FSIS that it had received consumer complaints reporting small metal pieces in the chicken patty product.

There has been one reported minor oral injury associated with consumption of this product. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

** FDA puts pressure on importers of cantaloupe, canned food, and dates

IA-12-10 Detention Without Physical Examination of Cheese Due to Microbiological Contamination https://www.accessdata.fda.gov/cms_ia/importalert_9.html
IA-16-81 Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella https://www.accessdata.fda.gov/cms_ia/importalert_49.html
IA-21-05 DETENTION WITHOUT PHYSICAL EXAMINATION OF DATES FROM PROC AND HONG KONG DUE TO FILTH https://www.accessdata.fda.gov/cms_ia/importalert_61.html
IA-22-01 Detention Without Physical Examination of Cantaloupes from Mexico https://www.accessdata.fda.gov/cms_ia/importalert_67.html
IA-45-02 Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors https://www.accessdata.fda.gov/cms_ia/importalert_118.html
IA-66-40 Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs https://www.accessdata.fda.gov/cms_ia/importalert_189.html
IA-66-41 Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. http://www.accessdata.fda.gov/cms_ia/importalert_190.html
IA-66-79 DWPE OF DRUGS FROM FOREIGN ESTABLISHMENTS REFUSING FDA INSPECTION None
IA-68-19 DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS https://www.accessdata.fda.gov/cms_ia/importalert_1147.html
IA-76-01 Detention Without Physical Examination Of Medical Instruments from Pakistan 2 https://www.accessdata.fda.gov/cms_ia/importalert_224.html
IA-80-06 Detention Without Physical Examination of Medical Devices with False or Misleading Labeling None
IA-89-04 Detention Without Physical Examination of Devices from firms that have not met Device Quality System Requirements https://www.accessdata.fda.gov/cms_ia/importalert_241.html
IA-89-08
Detention Without Physical Examination of Devices Without Approved PMAs or IDEs and Other Devices Not Substantially Equivalent or
Without a 510(k) https://www.accessdata.fda.gov/cms_ia/importalert_244.html
IA-98-06 New Tobacco Products Without Required Marketing Authorization None
IA-99-05 Detention Without Physical Examination of Raw Agricultural Products for Pesticides http://www.accessdata.fda.gov/cms_ia/importalert_258.html
IA-99-08 Detention Without Physical Examination Of Processed Human and Animal Foods for Pesticides https://www.accessdata.fda.gov/cms_ia/importalert_259.html
IA-99-22
Detention Without Physical Examination Of Foods Containing Undeclared Major Food Allergens Or Foods That Fail To Properly Label Major
Food Allergens https://www.accessdata.fda.gov/cms_ia/importalert_561.html
IA-99-34 DWPE of Drugs or Medical Devices from Firms without a Valid Drug or Medical Device Registeration https://www.accessdata.fda.gov/cms_ia/importalert_1125.html
IA-99-37
DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED
SCHEDULED PROCESSES https://www.accessdata.fda.gov/cms_ia/importalert_1131.html
IA-99-39 DETENTION WITHOUT PHYSICAL EXAMINATION OF IMPORTED FOOD PRODUCTS THAT APPEAR TO BE MISBRANDED https://www.accessdata.fda.gov/cms_ia/importalert_1144.html
IA-99-41
DWPE OF HUMAN AND ANIMAL FOODS IMPORTED FROM FOREIGN SUPPLIERS BY IMPORTERS WHO ARE NOT IN COMPLIANCE
WITH THE REQUIREMENTS OF FSVP REGULATION None
IA-99-42 DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS DUE TO HEAVY METAL (TOXIC ELEMENT) CONTAMINATION None
IA-99-47 DWPE OF HUMAN FOOD PRODUCTS THAT APPEAR TO BE ADULTERATED FOR ECONOMIC GAIN

** Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections

FOR IMMEDIATE RELEASE – October 31, 2023 – Dublin, OH, Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

** The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections

FOR IMMEDIATE RELEASE – October 31, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the consumer level. The Harvard Drug Group, LLC received information from FDA indicating investigator found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss of blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. The Harvard Drug Group, LLC has received three (3) reports of adverse events related to these products including reports of vision blurriness, vision loss, and burning eyes. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.