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Recall

Updated: May 6, 2022 1:00 PM
Natural Organics, Inc., is voluntarily recalling four lots of NaturesPlus Keto Living Sugar Control Capsules 90 count, because it was found to contain gluten. People who have allergies to wheat or gluten run the risk of serious or life-threatening allergic reactions if they consume these products. There... See More have been no reported incidents of illness or adverse reactions in connection with these products to date.

Individuals with Gluten intolerance may experience minor to severe reactions after consuming this product. This could include upset stomach, diarrhea, fatigue, skin reactions and more. It was discovered during routine testing that the product contains gluten. It was subsequently discovered that a raw material that is normally gluten free tested positive for gluten.

Gluten is a general name for the proteins found in wheat (wheatberries, durum, emmer, semolina, spelt, farina, farro, graham, KAMUT® khorasan wheat and einkorn), rye, barley, and triticale – a cross between wheat and rye.

The listed products were distributed nationwide to consumers, retail stores and to the following foreign countries: Kenya, Spain, Trinidad, United Arab Emirates, and the United Kingdom. The capsules are packaged in white jars and black caps; with labels having orange, white and black print bearing the product codes, lot numbers and “Best By” or “BBE” (Best Before End) dates are printed on the bottom of the bottle.

The lots affected are:

- NATURES PLUS KETO LIVING SUGAR CONTROL CAPSULES, 90 CAPSULES, Product No. 82004, UPC Code 097467820043, Lots 1362073, Best By 10/2025 and 1365200, Best By 10/2025
- NATURES PLUS KETO LIVING SUGAR CONTROL CAPSULES, 90 CAPSULES, Product No. Ue82004, UPC Code 097467820043, Lots 1361754, BBE 10/2025 and 1364325, BBE 10/2025

Consumers who may have purchased affected lots of NaturesPlus Keto Living Sugar Control Capsules are advised to return them to the place of purchase. No other Natural Organics, Inc. products are affected by this recall. Natural Organics, Inc. has removed all affected products within existing inventory.

This voluntary recall is announced in accord with FDA guidelines. We are initiating recall notices to our accounts and consumers who received inventory of the recalled products with instructions for returning the recalled products and for notifying their customers of the recall. Consumers with questions may contact the company Monday – Friday, from 8:00 am to 4:30pm EDT.

Company name: NATURAL ORGANICS, INC
Brand name: NaturesPlus
Product recalled: Keto Living Sugar Control Capsules
Reason of the recall: Undeclared Gluten
FDA Recall date: May 06, 2022

Source: fda.gov
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I ordered a sex performance booster online, it was recalled due to adverse effects. I had a stroke later the same day. It is "MegMen performance booster ". Im in Nashville, the company that sold me the recalled over the counter drug is in New York. According... See More I need help finding a lawyer to help me? See Less
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Royal Philips (NYSE: PHG, AEX: PHIA), today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics... See More has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance.

Philips Respironics projects an average of less than one silent shutdown among one million uses per year. Philips Respironics is advising customers that they must implement one or more of the following actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue:

- Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680; and/or
- Connect the V60/V60 Plus or V680 to a nurse call/remote alarm system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse call/remote alarm capability; and/or
- Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.

Additionally:
- An alternative means of ventilation should be available whenever the V60/V60 Plus or V680 ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such an alternative device. The ventilator must be removed from clinical use and serviced by authorized service personnel.

If these mitigations are not available, Philips Respironics recommends each institution deliberately make a decision that balances the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of ceasing use and/or substituting other ventilators. Such decision-making should consider the institution’s capabilities and patient needs.

Philips Respironics is committed to addressing the issue and will provide regular updates to customers on the development of its plan to address the issue, with the first update to be provided before June 30, 2022. The V60/V60 Plus is not a life support ventilator. It is an assist ventilator and is intended to augment patient breathing. The V680 ventilator provides invasive and non-invasive respiratory support. The V60/V60 Plus and V680 ventilators are not authorized for use in a home or non-institutional setting.

Company name: Philips Respironics
Brand name: Philips Respironics
Product recalled: V60/V60 Plus, and V680
Reason of the recall: A potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm
FDA Recall date: May 02, 2022

Source: fda.gov
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Boil Water Alerts for Businesses
Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including... See More cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.i Accupril is indicated for the treatment of hypertension, to lower blood pressure. 

Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. Accupril® (Quinapril HCl Tablets), 10 mgAccupril® (Quinapril HCl Tablets), 20 mgAccupril® (Quinapril HCl Tablets), 40 mg.

NDC: 0071-0530-23
Lot Number: DR9639
Expiration Date: 2023 MAR 31
Strength: 10 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DX8682
Expiration Date: 2023 MAR 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DG1188
Expiration Date: 2022 MAY 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: DX6031
Expiration Date: 2023 MAR 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: CK6260
Expiration Date: 2022 MAY 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.

Company name: Pfizer
Brand name: Pfizer
Product recalled: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Reason of the recall: Due to N-Nitroso-Quinapril Content
FDA Recall date: April 22, 2022

Source: fda.gov
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Babyganics is voluntarily recalling two lots of 20-ounce bottles of babyganics® 20oz chamomile verbena bubble bath, due to the presence of the bacterium Pluralibacter gergoviae. The products were sold in the last two months only at select retailers in the U.S.

During internal testing related to product... See More shelf life across the Babyganics bubble bath line, it was discovered that two specific lot numbers of this product contained the bacterium. While infants may be more susceptible than adults, Pluralibacter gergoviae does not usually cause healthy individuals to become sick. However, it may pose a risk of infection to those who are immunocompromised or have broken or irritated skin, such as diaper rash.

The only products affected are babyganics® 20oz chamomile verbena bubble bath UPC 8 13277 01375 4 with lot codes Y314 and Y315 found at the bottom of the packaging and contained in a white plastic bottle with a green plastic lid.

The testing confirmed that no other Babyganics products contained this bacterium. Babyganics takes pride in its commitment to vigorous consumer safety standards and providing peace of mind for parents, which is why the decision was made to voluntarily recover these bottles from retailers and to proactively reach out to consumers. Consumers with the affected product will be provided with a full refund after submitting their product and contact information at the company website. Consumers who have come into contact with the affected product and aren’t feeling well should contact their doctor.

Company name: Babyganics
Brand name: Babyganics
Product recalled: Chamomile verbena bubble bath
Reason of the recall: Presence of the bacterium Pluralibacter gergoviae, a bacterium
FDA Recall date: April 20, 2022

Source: fda.gov
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Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level.... See More To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. 

Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

These products are indicated for the treatment of hypertension.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables in the link below and photos of the products can be found below. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022.

- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
- quinapril and hydrochlorothiazide tablets, 20/25 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/25 mg

Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

Company name: Pfizer
Brand name: Accuretic, Greenstone Brand
Product recalled: Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets
Reason of the recall: Presence of a nitrosamine, N-nitroso-quinapril
FDA Recall date: March 22, 2022

Source: fda.gov
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Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential clogging of... See More the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes SYMJEPI in the United States, under license from Adamis, the NDA holder.

USWM will handle the entire recall process for Adamis, with Adamis oversight. SYMJEPI is manufactured and tested for Adamis by Catalent Belgium S.A. Risk Statement: If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date.

However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall. The recall encompasses all of the following batches, within expiry:

+ SYMJEPI (epinephrine) Injection.
-- Strength: 0.15 mg/0.3 mL. NDC: 78670-131-02. Lot: 21101Y. Expiration: 11/30/2022
-- Strength: 0.3 mg/0.3 mL. NDC: 78670-130-02. Lot | Expiration: 21041W | 8/31/2022. 21081W | 11/30/2022. 21102W | 2/28/2023

SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

The products are packaged in 2-count Pre-Filled Single-Dose Syringes per carton and were distributed nationwide in the USA and directly to customers and/or medical facilities. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons below.

Company name: Adamis Pharmaceuticals Corporation
Brand name: Adamis Pharmaceuticals Corporation
Product recalled: SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes
Reason of the recall: Potential clogging of the needle preventing the dispensing of epinephrine
FDA Recall date: March 22, 2022

Source: fda.gov
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Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to be above the U.S. Food... See More and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing.

These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021. Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and 1000-count bottles and was distributed nationwide in the USA to wholesalers and distributors.

- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: JX6411. Expiration Date: May 22. Date of Manufacture: 5/24/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: JX6413. Expiration Date: May-22. Date of Manufacture: 5/24/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KC0723. Expiration Date: Aug-22. Date of Manufacture: 8/21/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KC3303. Expiration Date: Aug-22. Date of Manufacture: 8/21/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE4348. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE7169. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE4349. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KL3199. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KM0072. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0815-022-10. Lot Number: KS3939+. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA7704. Expiration Date: Oct-23. Date of Manufacture: 10/6/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA7703. Expiration Date: Oct-23. Date of Manufacture: 10/6/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA9243. Expiration Date: Oct-23. Date of Manufacture: 11/18/2020

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed above and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product. Any product returned that is not associated with this recall will be destroyed, and no credit will be issued.

Sandoz is notifying its wholesalers and distributors by mail and is arranging for the return of all recalled product. Wholesalers and distributors that have Orphenadrine Citrate ER Tablets subject to this recall should immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription.

Company name: Sandoz, Inc.
Brand name: Sandoz
Product recalled: Orphenadrine Citrate 100 mg Extended Release (ER) Tablets
Reason of the recall: Presence of a Nitrosamine Impurity
FDA Recall date: March 22, 2022

Source: fda.gov
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Kao USA Inc. is asking consumers to check their Jergens® Ultra Healing Moisturizer 3 oz and 10 oz products to determine if it is part of a voluntary recall of the product. Select units of Jergens® Ultra Healing Moisturizer could show the presence of Pluralibacter gergoviae, a... See More bacterium which typically poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems may be more susceptible to infections.

Kao USA is urging consumers to discontinue use of the recalled lotion specified below as a precautionary measure. Further investigation to determine the scope of the issue is still ongoing. However, Kao USA Inc. promptly took the precautionary step of issuing a voluntary recall of the affected product by removing the product in question from warehouses, working with retailers to ensure the product is removed from store shelves, and proactively notifying consumers.

The amount of recalled product is limited to two sizes offered for Jergens® Ultra Healing Moisturizer. Only specific lots of the 3 oz and 10 oz sizes are affected.

IDENTIFYING THE AFFECTED PRODUCTS:
- Jergens® Ultra Healing Moisturizer, manufactured between October 1, 2021 and October 18, 2021, could be impacted.
- The affected lot codes for the 3 oz size (UPC 019100109971 for single bottles and 019100267114 for pack of 3) can be found on the back of the bottle printed in black ink and begin with the prefix "ZU": ZU712851 | ZU712871 | ZU712911 | ZU722881 | ZU712861 | ZU712881 | ZU722851
- The affected lot codes for the 10 oz size (UPC 019100109988) can be found on the bottom of the bottle printed in black ink and begin with the prefix "ZU": ZU722741 | ZU722781 | ZU732791 | ZU732811 | ZU722771 | ZU732781 | ZU732801 | ZU732821

Anyone who has product from a recalled lot should call the Kao USA Inc. Consumer Care Center. A postage paid label and plastic bag will be sent to consumers via mail to easily return the product.

Company name: Kao USA Inc.
Brand name: Jergens
Product recalled: Ultra Healing Moisturizer
Reason of the recall: Presence of Pluralibacter gergoviae, a bacterium
FDA Recall date: March 18, 2022

Source: fda.gov
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Republic of Munchery Limited is recalling several pet feed products because of the presence of salmonella in one of the ingredients used to manufacture the products listed below.

The recalled products are:

- Wilsons Cold Pressed Haggis (2kg and 10kg), best before: 07 January 2023
- Wilsons... See More Cold Pressed Succulent Chicken (2kg and 10kg), best before: All dates from 15 December 2022 up to and including 17 February 2023
- Wilsons Cold Pressed Grass Fed Lamb (2kg and 10kg), best before: All dates from 13 December 2022 up to and including 10 February 2023
- Wilsons Cold Pressed Clear Water Salmon (2kg and 10kg), best before: All dates from 15 December 2022 up to and including 23 February 2023
- Wilsons Cold Pressed Farmhouse Turkey and Duck (2kg and 10kg), best before: All dates from 10 December 2022 up to and including 22 February 2023
- Wilsons Cold Pressed Highland Venison and Trout (2kg and 10kg), best before: All dates from 16 December 2022 up to and including 14 February 2023
- Wilsons Cold Pressed Wild White Fish (2kg and 10kg), best before: All dates from 14 December 2022 up to and including 2 February 2023
-Wilsons Cold Pressed Working Dog Beef (15kg), best before: All dates from 13 December 2022 up to and including 23 February 2023
- Wilsons Cold Pressed Working Dog Chicken (15kg), best before: All dates from 14 December 2022 up to and including 23 February 2023
- Wilsons Cold Pressed Working Dog Pork (15kg), best before: All dates from 20 December 2022 up to and including 21 February 2023

If you have bought any of the above products do not use them. Instead, return them to the store from where they were bought for a full refund.

Salmonella is a bacterium that can cause illness in humans and animals. The products could therefore carry a potential risk, because of the presence of salmonella, either through direct handling of the product, or indirectly, for example from pet feeding bowls, utensils or contact with the faeces of animals.

Company name: Republic of Munchery Ltd
Brand name: Republic of Munchery Ltd.
Product recalled: Wilsons Cold Pressed Haggis, Wilsons Cold Pressed Succulent Chicken, Wilsons Cold Pressed Grass Fed Lamb, Wilsons Cold Pressed Clear Water Salmon, Wilsons Cold Pressed Farmhouse Turkey and Duck, Wilsons Cold Pressed Highland Venison and Trout, Wilsons Cold Pressed Wild White Fish, Wilsons Cold Pressed Working Dog Beef, Wilsons Cold Pressed Working Dog Chicken, Wilsons Cold Pressed Working Dog Pork
FSA Recall date: 03/14/2022

Check the full recall details on food.gov.uk

Source: FSA
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