12/26/23- Tampa Bay Fisheries, Inc. “365 Whole Foods Market Beer Battered Polluck Fillets”

TAMPA BAY FISHERIES, INC. IS VOLUNTARILY RECALLING ONE LOT OF 365 WHOLE FOODS MARKET “BEER BATTERED POLLOCK FILLETS” (32OZ) BAGS WITH UPC 9948249803, LOT# 32508201, AND BEST BUY: 03/07/2025 LOCATED ON THE BACK OF BAG. 2 LOTS OF 365 WHOLE FOODS MARKET “BEER BATTERED COD FILLET” (12OZ) CARTONS WITH UPC 9948248051, LOT# 32348201 AND BEST BY: 02/22/2025. LOT# 32628201 WITH A BEST BY: 03/19/2025 LOCATED ON THE END SIDE OF THE CARTON.

THE PRODUCT CONTAINS SOY WHICH IS NOT DECLARED ON THE PRODUCT LABEL

PRODUCT UPC LOT# BEST BY
365 WHOLE FOODS MARKET “BEER BATTER POLLOCK” (32OZ) BAGS 9948249803 32508201 03/07/2025
365 WHOLE FOODS MARKET “BEER BATTER COD” (12OZ) CARTONS 9948248051 32348201 02/22/2025
32628201 03/19/2025

THE LOT NUMBER AND BEST DATE ARE LOCATED ON THE BACK OF THE 365 WHOLE FOODS MARKET “BEER BATTERED POLLOCK FILLETS” (32OZ) BAGS.

THE LOT NUMBER AND BEST DATE ARE LOCATED ON THE END SIDE BACK OF 365 WHOLE FOODS MARKET “BEER BATTERED COD FILLETS” (12OZ) CARTONS.

PEOPLE WHO HAVE AN ALLERGY OR SEVERE SENSITIVITY TO SOY RUN THE RISK OF SERIOUS OR LIFE-THREATENING ALLERGIC REACTION IF THEY CONSUME THIS PRODUCT.

THE AFFECTED PRODUCT WAS AVAILABLE FOR PURCHASE AT WHOLE FOODS MARKET STORES NATIONWIDE BETWEEN 9/8/2023 THROUGH 12/22/2023.

NO ILLNESSES HAVE BEEN REPORTED TO DATE. THE RECALL WAS INITIATED AFTER IT WAS DISCOVERED THAT PRODUCT CONTAINING SOY WAS DISTRIBUTED IN PACKAGING THAT DID NOT REVEAL THE PRESENCE OF SOY.

NO OTHER LOTS WERE FOUND TO BE AFFECTED. THE AFFECTED PRODUCT HAS BEEN REMOVED FROM STORE SHELVES.

CONSUMERS WHO HAVE PURCHASED THIS PRODUCT AT WHOLE FOODS MARKET SHOULD NOT CONSUME THE PRODUCT AND SHOULD DISPOSE OF THE PRODUCT. CONSUMERS CAN BRING A VALID RECEIPT INTO STORES FOR A FULL REFUND.

CONSUMERS WITH QUESTIONS MAY CONTACT TAMPA BAY FISHERIES, INC. AT (800)-SEAFOOD, MONDAY-FRIDAY 8AM TO 5PM EASTERN.

TAMPA BAY FISHERIES, INC.
3060 N. GALLAGHER ROAD
DOVER, FLORIDA 33527

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tampa-bay-fisheries-inc-dover-florida-voluntarily-recalling-1-lot-365-whole-foods-market-beer

WIC participation on the rise in Missouri as WIC celebrates 50 years of service

October marked the start of the 50th year of WIC services in the United States. Missouri WIC begins this celebration with an overall increase of 7.7% in participation over the last federal fiscal year (FFY). WIC is the Special Supplemental Nutrition Program for Women, Infants and Children. The program provides quality nutrition education, breastfeeding promotion and support, nutritious foods and referrals to health services.
A recent report from the USDA showed Missouri to be among seven states with consistently lower than national eligible participation rates in FFY 2021. Missouri WIC’s overall participation decrease occurred over several years with a sharper decrease during the pandemic when it was difficult to access WIC benefits in person. In an effort to improve access to WIC services and to improve the benefit redemption process, Missouri WIC actively pursues outreach opportunities and technology advancements.
· In the last year, ongoing outreach strategies in collaboration with the Department of Social Services, MO HealthNet Division, and its health plan partners, to improve communication of WIC program eligibility and WIC program benefits to MO HealthNet program participants was implemented.
· On August 10, 2023, new policies took effect under a USDA physical presence waiver, allowing aspects of WIC services to be provided virtually or over the phone to respond to participant requests for remote access to WIC services.
· In the current FFY, participants will receive increased amounts in their fruits and vegetables cash value benefit (CVB) providing more healthy foods each month.
· Before the end of 2024, Missouri WIC will move from an “offline” EBT card system, which requires in-person loading and benefit redemption, to an “online” EBT card system, which removes the in-person requirement allowing for more flexibility in the program.
Removing technology and remote service barriers, along with improved direct communication to eligible individuals is expected to continue to have a positive impact on WIC participation.
Missouri WIC offers healthy food choices that target specific essential nutrients often missing from the diets of participants, such as iron, calcium, protein, and vitamins A, C, and D. To meet these needs, the WIC food package includes fresh or frozen fruits and vegetables, whole grains, milk and yogurt along with other nutritious foods.
To qualify for the WIC program, participants must meet the following requirements:
· Be a pregnant, breastfeeding or new mother; an infant up to age one; or a child up to their 5th birthday.
· Be a resident of Missouri.
· Meet income eligibility requirements.
Missourians interested in learning about the benefits of WIC may visit [wic.mo.gov]WIC.Mo.Gov or call TEL-LINK at 1-800-835-5465 to find the WIC local agency in their county.

11/29/23: Seneca Foods Corporation “Hy-Vee Turkey gravy in glass jars”

Seneca Foods Corporation is announcing a voluntary recall of mislabeled Hy-Vee Turkey gravy in glass jars that actually contains beef gravy. This product could potentially contain a soy allergen which is not declared on the label. Seneca is now retrieving improperly labeled Hy-Vee Turkey Gravy from its distribution system. This recall only affects Hy-Vee Turkey Gravy product sold by Hy-Vee. No other retailers are affected. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

Seneca is not aware of any reports of consumer illness related to this product.

The recall extends to the following labels and package sizes ONLY:

Hy-Vee Turkey Gravy (12 oz glass jars)
UPC: 75450-03608
– Individual Lot Code On Lid:
A3CG162M A3CG192M

Please note this recall impacts less than 1% of this particular product sold in Hy-Vee stores. Consumers with this product should return it for a full refund to the retail outlet where it was purchased. Consumers who want more information may call Seneca Foods Consumer Affairs at 1-800-872-1110.


COMPANY CONTACT INFORMATION

Consumers:

Seneca Foods Consumer Affairs

1-800-872-1110

Media:

Matt Henschler, Seneca Foods Corporation

(608) 757-6054

 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-food-recall-because-potential-undeclared-allergen-due-mislabel

11/9/23- Sofia Produce, LLC dba Trufresh, “Fresh Cantaloupe”

UPDATE: November 22, 2023 SOFIA PRODUCE, LLC, of Nogales, Arizona which does business under the name “Trufresh” (“Trufresh”) has expanded its recall of all sizes of fresh cantaloupes packaged in cardboard containers labeled with the “Malichita” label, and also labeled with the “Rudy” label to include all cantaloupes sold between the dates of October 10, 2023 and November 3, 2023, because they have the potential to be contaminated with Salmonella.

Resources:

 FDA Recalls:
o 11/16/2023: https://www.fda.gov/safety/recalls-market-withdrawals-safetyalerts/sofia-produce-llc-dba-trufresh-expands-recall-include-additional-ordernumbers-fresh-cantaloupe
o 11/9/2023: https://www.fda.gov/safety/recalls-market-withdrawals-safetyalerts/sofia-produce-llc-dba-trufresh-recalls-fresh-cantaloupe-because-possiblehealth-risk-due-salmonella
 FDA Outbreak Investigation of Salmonella: Cantaloupes:
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigationsalmonella-cantaloupes-november-2023
 CDC Investigation Details: https://www.cdc.gov/salmonella/sundsvall-11-23/details.html
 CDC Salmonella Outbreak Linked to Cantaloupes:
https://www.cdc.gov/salmonella/sundsvall-11-23/index.html
 CDC Salmonella: https://www.cdc.gov/salmonella/index.html
 FDA Salmonella: https://www.fda.gov/food/foodborne-pathogens/salmonellasalmonellosis

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 Cantaloupes were distributed directly to the following States in the United States: Arizona, California. Maryland, New Jersey, Tennessee, Illinois, Michigan, Wisconsin, Texas, Florida and Canada. The Cantaloupes would have reached consumers through retail produce markets which may be located in states other than those listed above.

The Cantaloupes are packaged in cardboard containers bearing the “Malichita” Label (picture attached). The cantaloupes also have an individual PLU sticker placed upon each cantaloupe in the form of the attached picture. As shown in the picture, the PLU sticker has a top half which is white which has the word “Malichita” written in script in black letters. The bottom of the PLU sticker is black and has the number “4050” prominently displayed in white letters together with the words “Product of Mexico/produit du Mexique”. This label will identify individual Malichita cantaloupes purchased by consumers.

There have been no reported illnesses associated with the subject cantaloupes, to date.

Trufresh is performing this recall after the Canadian Food Inspection Agency announced a similar recall of cantaloupes packaged with the same Malichita label and bearing the same PLU due to possible salmonella contamination for cantaloupes sold to Fruits et Légumes Gaétan Bono. The Canadian Food inspection Agency Announcement can be found here: https://recalls-rappels.canada.ca/en/alert-recall/malichita-brand-cantaloupes-recalled-due-salmonellaExternal Link Disclaimer . Trufresh’s investigation has revealed that the above-listed order numbers may have been associated with the cantaloupes sold to Fruits et Légumes Gaétan Bono.

Consumers should take the following actions:

  • Check to see if you have recalled products
  • Do not consume, serve, use, sell, or distribute recalled products
  • Recalled products should be thrown out or returned to the location where they were purchased
  • Consumers who are unsure if they have purchased the recalled product are advised to contact their retailer.
  • If you think you became sick from consuming a recalled product, contact your healthcare provider

Information for Buyers:

  • Trufresh is contacting each of the individual buyers under the foregoing orders to advise them of the recall. If the buyers associated with the above sales order numbers have not already been contacted by Trufresh, they should contact Trufresh at the number below.
  • Buyers associated with the above sales order numbers should remove any remaining product from their sales inventory.
  • The Buyers should then dispose of the product and retain their records of disposal.
  • Order Numbers: 0128556, 0128624, 0128630, 0128632, 0128640, 0128643, 0128644, 0128646, 0128648, 0128651, -0128656, 0128669, 0128680, 0128682, 0128683, 0128700, 0225200, 0225201, 0225206, 0225214, 0225219, 0225222, 0225226, 0225227, 0225228, 0419611, 0419629, 0419630, 0419636, 0419671, 0419688, 0419693, 0419696, 0419697, 0419704, 0419710, 0419718, 0419772, 0516255, 0516268, 0516271, 0516279, 0516301, 0612143, 0612144, 0612148, 0612154, 0612156, 0612158, 0612171, 0612190, 0612191, 0612197, 0612198, 0612209, 0612225

Consumers who have purchased the recalled products may obtain additional information by contacting Rafael Roiz, Tru Fresh’s representative Monday through Friday between the hours of 8:00 a.m. and 5:00 p.m. Mountain Standard Time at (520) 394-7370.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sofia-produce-llc-dba-trufresh-recalls-fresh-cantaloupe-because-possible-health-risk-due-salmonella

11/17/23- HMC Group Marketing, Inc. “Peaches, Plums and Nectarines”

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.

This recall includes only conventionally grown fruit – no organic fruit is being recalled. Peaches, plums, and nectarines currently available for sale at retail stores are not included in this recall.

The recalled peaches have been linked to an outbreak of LISTERIOSIS that has resulted in eleven illnesses.

Consumers: Although the recalled fruit is no longer available in retail stores, consumers may have frozen the recalled fruit at home for later use. CONSUMERS ARE URGED TO CHECK THEIR FREEZERS for the recalled fruit, not consume it, and discard it. Consumers with further questions can contact the company’s consumer information desk at 844-483-3867, Monday-Friday, 8:00 a.m. – 8:00 p.m. Eastern Time.

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


COMPANY CONTACT INFORMATION

Consumers:

844-483-3867

Media:

Amy Philpott

703-472-6615

 amy@philpott-prsolutions.com

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hmc-farms-voluntarily-recalls-whole-peaches-plums-and-nectarines-sold-retail-stores-2022-and-2023

11/17/23- Raw Sea Foods, INC “Farm Raised Lightly Seasoned Atlantic Salmon Burgers”

Raw SeaFoods, Inc. of Fall River, MA is recalling Farm Raised Lightly Seasoned Atlantic Salmon Burgers due to undeclared sesame and milk allergens. People who have an allergy or sensitivity to sesame and/or milk may have a serious or life-threatening allergic reaction if they consume this product.

The recalled product was sold in the seafood department of Whole Foods Market stores nationwide from August 25, 2023 through November 15, 2023. This product was sold from the seafood service case wrapped in paper or prepackaged in clear trays displaying PLU 56228:

Product Name

PLU Code

Sell By Date

Farm Raised Lightly Seasoned Atlantic Salmon Burger

56228

9/11/23-
11/19/23

Only the Farm Raised Lightly Seasoned Atlantic Salmon Burgers with the PLU code and sell by dates listed above are impacted.

The problem was discovered after a vendor reported visible sesame seeds present on the product. An investigation is currently under way to discover the cause. No illnesses have been reported to date.

Consumers with an allergy or sensitivity to sesame or milk should not consume the product. Customers who purchased this product at Whole Foods Market can bring a valid receipt into stores for a full refund. Consumers with any questions may contact Raw SeaFoods, Inc. at 508-673-0111 Monday – Friday between the hours of 8am and 5pm EST.

Raw SeaFoods, Inc. is taking the necessary steps to address this issue and apologizes for any inconvenience caused. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


COMPANY CONTACT INFORMATION

Consumers:

Raw SeaFoods

508-673-0111

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/raw-seafoods-inc-issues-allergy-alert-undeclared-sesame-and-milk-farm-raised-lightly-seasoned

 

 

11/3/23- WanaBana USA “WanaBana Apple Cinnamon Fruit Purée pouches”

WanaBana USA is voluntarily recalling WanaBana Apple Cinnamon Fruit Purée pouches due to reports of elevated levels of lead found in certain units of the product.

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

Longer term exposure could result in additional symptoms:

  • Irritability
  • Lethargy
  • Fatigue
  • Muscle aches or muscle prickling/burning
  • Occasional abdominal discomfort
  • Constipation
  • Difficulty concentrating/Muscular exhaustibility
  • Headache
  • Tremor
  • Weight loss

WanaBana Apple Cinnamon Fruit Purée Pouches were distributed nationwide through online and retail stores. The affected product information is as follows:

The product is also distributed independently in the US as private label brands under the names of Schnucks Apple Sauce 90g pouches with cinnamon. The affected Schnucks lots subject of the product recall were identified as 05023:19, 09023:22 and 09023:24.

Product Name: WanaBana Apple Cinnamon Fruit Puree in 3-pack pouches of 2.5 oz. Affected Batches:

Batch Units   Batch Units
10022:21 33165 01023:03 48735
11022: 08 22185 01023:17 62235
11022:09 23730 01023:23 67590
11022:10 33420 01023:27 60975
11022:12 12120 01023:30 101205
11022:14 29025 01023:31 99180
11022:15 32085 02023:07 84780
11022:16 34860 02023:18 129600
12022:23 64170 04023:23 96090
04023:24 138240
04023:25 64395
04023:26 68805
05023:08 85950
05023:09 101520
05023:10 89460
05023:11 95535
05023:15 88605
10022:31 33165

WanaBana USA has initiated a voluntary recall of the affected batches and is working closely with the FDA to investigate the source of the contamination. The company is committed to ensuring the safety of its products and the well-being of its consumers.

Four illnesses have been reported to date, leading North Carolina Department of Agriculture and Consumer Services and the North Carolina Department of Health and Human Services to investigate and sample the pouches. North Carolina’s analyses came back with elevated concentrations of lead which could result in acute toxicity. WanaBana USA is working to investigate the source of the contamination.

Consumers who have purchased WanaBana Apple Cinnamon Fruit Puree Pouches with the specified batch numbers and expiration dates are urged to stop using the product immediately and return it to the place of purchase for a full refund. Parents and caregivers of toddlers and young children who may have been exposed to lead should contact their health care provider to report their symptoms and receive care. Consumers with questions can email the company at support@wanabanafruits.com.

FDA Advisory


COMPANY CONTACT INFORMATION

Consumers:

Wanabana LLC

 support@wanabanafruits.com

Media:

Karen Garnik

 karen@globalvisioncomms.com

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wanabana-issues-voluntary-recall-wanabana-apple-cinnamon-fruit-puree-pouches-due-elevated-lead

11/3/23-Cardinal Health “all lots of ophthalmic products supplied by Velocity Pharma, LLC”

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.

These products are available as over the counter (OTC) products used for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye, and/or to relieve redness of the eye due to minor eye irritations.

These products can be identified on the outer carton labeling as follows:

Product Name Package
Description
Brand
Name
NDC
Eye Irritation Relief (Polyvinyl Alcohol,
0.5%, Povidone, 0.6%, and
Tetrahydrozoline Hydrochloride, 0.05%)
0.5 FL OZ bottle
(15 mL)
LEADER™ 70000-0087-1
Dry Eye Relief
(Carboxymethylcellulose Sodium, 1%)
0.5 FL OZ bottle
(15 mL)
LEADER™ 70000-0089-1
Lubricant Eye Drops
(Carboxymethylcellulose Sodium, 0.5%)
0.5 FL OZ bottle
(15 mL)
LEADER™ 70000-0090-1
Lubricant Eye Drops
(Carboxymethylcellulose Sodium, 0.5%)
2 bottles, 0.5 FL
OZ (15 mL) each
LEADER™ 70000-0090-2
(Carton)
70000-0090-1
(Bottle)
Dry Eye Relief (Polyethylene Glycol 400,
0.4% and Propylene Glycol, 0.3%)
0.33 FL OZ bottle
(10 mL)
LEADER™ 70000-0088-1
Lubricant Eye Drops
(Propylene Glycol, 0.6%)
0.33 FL OZ bottle
(10 mL)
LEADER™ 70000-0587-1

Images of the outer carton labeling of these listed products can be found below.

Products were distributed Nationwide to Wholesalers and Retailers starting December 12, 2021.

Cardinal Health, Inc. is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-855-215-4940 (8:00am-5:00pm EST Monday through Friday) or by email at Cardinalhealth7720@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-inc-issues-voluntary-nationwide-recall-certain-leadertm-brand-eye-drops-supplied

11/3/23- The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories ” all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%)”

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.

Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter (OTC) products used for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun and the product used as a protectant against further irritation or to relieve dryness of the eye.

Both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be identified on the outer carton labeling as follows:

Brand Name Product Name Package
Description
NDC
Rugby® Polyvinyl Alcohol, 1.4%
Lubricating Eye Drops
0.5 oz bottle (15 mL) 0536-1325-94
Rugby® Lubricating Tears Eye Drops
(Dextran/Hypromellose,
0.1%/0.3%)
0.5 oz bottle (15 mL) 0536-1282-94

Images of the outer carton labelling of both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be found below.

Products were distributed Nationwide starting June 1, 2021.

The Harvard Drug Group, LLC is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye