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Recall

Updated: January 19, 2022 12:02 PM
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label... See More to be missing on some prefilled pens within a labelled carton for this particular batch. This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:

- Semglee® (insulin glargine injection). Strenght: 100 units/mL (U-100). Size: 3mL Prefilled Pen. NDC #49502-196-75. Batch#: BF20003118. Expiry: August 2022

Risk Statement: A missing label on Semglee® (insulin glargine) prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin.

Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, the company has not received any reports of adverse events related to this recall.

This recall does not pertain to the recently launched interchangeable biosimilars, Semglee® (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefilled pens in cartons of five (5) pens. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for consumers, wholesalers, and retailers.

- Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.
- Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please check the link below for further actions.
- Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.

Company name: Mylan Pharmaceutical Inc.
Brand name: Semglee
Product recalled: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens
Reason of the recall: Missing Label
FDA Recall date: January 19, 2022

Check the full recall details on fda.gov

Source: FDA
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Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing... See More life-threatening inflammation of the heart, could result in infections that could be life-threatening.

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

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label attached.

Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers. Outer carton labeling (see images) Unit-Dose Cups (see image) Lohxa LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

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.

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

Company name: Lohxa LLC
Brand name: AVpak
Product recalled: Senna Syrup 5mL
Reason of the recall: Potential microbial contamination
FDA Recall date: January 12, 2022

Check the full recall details on fda.gov

Source: FDA
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Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal... See More on the proximal end of the device handle detaching during use.

RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.

Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.

PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information below (1, 2, and 3).

The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.

Recalled Product Impacted (1)

- Destino Twist 14F (DST1405525). UDI Number: 885672011123. Lot Number: PQOC13475. Expiration Date 10-01-2021. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14073. Expiration Date 11-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14072. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14071. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13834. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13828. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13827. Expiration Date 08-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12995. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12632. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12633. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12345. Expiration Date 06-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12330. Expiration Date 06-01-2025. Packaging State Type: Sterile.

Destino 14F Twist Model (2)

Product: Destino Twist 14F
GTIN (Unit): 00885672011123
Model: DST1405525
Sheath & Dilator: S55CM D73CM
French Size: 14F
Quantity: 6 Units

Guidestar 14F - Model (3)

Product: Guidestar 14F
GTIN (Unit): 00885672010911
Model: D141103
Sheath & Dilator: S71CM D89CM
French Size: 14F
Quantity: 543 Units

Company name: Oscor Inc.
Brand name: Oscor
Recalled: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Reason of the recall: Hub cap and seal on the proximal end of the device handle may detach during use
FDA Recall date: January 12, 2022

Check the full recall details on fda.gov

Source: FDA
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World Health Products, llc. of Monroe, CT is recalling Jetfuel Diuretic UPC 859613000859, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

The GAT Sport Jetfuel... See More Diuretic was distributed thru the GAT Sport online store, Amazon and “Nationwide” retail stores. The recalled products bear the following lot code and Expiration Date information:

Brand: GAT Sport / Jetfuel Diuretic
Product: Jetfuel Diuretic
Size: 90 ct Bottle
Lot # 2003609
Exp. Date: 6/2023

Brand: GAT Sport / Jetfuel Diuretic
Product: Jetfuel Diuretic
Size: 90 ct Bottle
Lot # 2003610
Exp. Date: 5/2023

The lot code and expiration date are located on the bottom of the container, in bottom center of the panel, as pictured below.

This recall is being initiated because the Medium-Chain Triglycerides (MCT) oil powder ingredient contains an undeclared milk allergen.

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

To date there have been no reports of illness involving the products addressed in this recall.

Customers with a milk allergy or sensitivity who have purchased the affected product are urged not to consume it and dispose of it or return it to the point of purchase.

In case you are experience harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: World Health Products, LLC
Brand name: GAT Sport Jetfuel Diuretic
Product recalled: Diuretic
Reason of the recall: May contain undeclared milk
FDA Recall date: January 06, 2022

Check the full recall details on fda.gov

Source: FDA
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ALDI is voluntarily recalling Pure Being Cat Advent Calendars and Pure Being Dog Advent Calendars as a precautionary measure due to a potential choking hazard. After receiving a small number of customer complaints and discussion with the supplier, ALDI immediately removed the affected products from stores. The... See More affected products are:

- Pure Being Cat Advent Calendar (5.15 oz Box). UPC: 4099100267754. Best If Used By: All
- Pure Being Dog Advent Calendar (5.15 oz Box) UPC: 4099100267747. Best If Used By: All

No other ALDI products are affected by this recall.

ALDI takes the safety and integrity of the products it sells seriously. If customers have product(s) affected by this voluntary recall, they should discard it immediately or return it to their local store for a full refund.

Customers may contact Pet Brands Products’ Customer Service at 866-396-3647 for more information.

Company name: ALDI
Brand name: Pure Being
Product recalled: Advent Calendars for Cats and Dogs
Reason of the recall: Potential choking hazard
FDA Recall date: January 04, 2022

Check the full recall details on fda.gov

Source: FDA
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Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of... See More this product are impacted.

Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing. R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment. If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues.

To date, Taro has not received any adverse event reports related to this lot.

The one (1) lot being recalled is as follows:

Lot # AC13786
Amount: 96 units
Expiration Date: December 2022

Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses and is packaged in 60 g aluminum tubes with polypropylene puncture-tip caps. Each 60 g tube is labeled to indicate the name of the product, Clobetasol Propionate Ointment USP, 0.05% and the NDC # 51672-1259-3 (see image of container label below). The Lot Number and Expiration Date are displayed on the bottom of each tube and the end flap of the product carton.

Ninety-six (96) units of Lot AC13786 were distributed to two wholesale distributors in the U.S. market between November 16 and December 6, 2021. These two wholesale distributors may have further distributed this lot to their retail customers for prescription dispensing to patients who were prescribed Clobetasol Propionate Ointment USP, 0.05%, 60 g.

Retail customers that have any quantities of Lot AC13786 which is being recalled, should stop distribution and return any unsold units to their wholesaler. 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.

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

Company name: Taro Pharmaceuticals USA, Inc.
Brand name: Taro
Product recalled: Clobetasol Propionate
Reason of the recall: Presence of Ralstonia pickettii bacteria
FDA Recall date: December 30, 2021

Check the full recall details on fda.gov

Source: FDA
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Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received... See More that a unit may not dispense.

There is a risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication.

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 150892
- Expiration: Oct 2022

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 153199
- Expiration: Feb 2023

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 156041
- Expiration: Apr 2023

Company name: Padagis
Brand name: Perrigo
Product recalled: Nitroglycerin Lingual Spray
Reason of the recall: Unit may not properly dispense medication.
FDA Recall date: December 27, 2021

If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12 g bottle contained within a carton. The medication was distributed Nationwide in the USA to wholesalers and retailers.

Healthcare providers, distributors, and retailers that have product which is being recalled should stop distribution. Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product.

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

Check the full recall details on fda.gov

Source: FDA
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Woody’s Pet Food Deli is recalling Raw Cornish Hen pet food “With Supplements” sticker due to a Salmonella health risk. The product was distributed in the company’s retail stores in Minneapolis, Saint Paul, and Woodbury, Minnesota.

Salmonella can affect animals eating the product and there is risk... See More to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

- Woody’s Pet Food Deli RAW CORNISH HEN with SUPPLEMENTS (5 lb. plastic tub). PLU Code 5230. Expiration date 11/20/22
- Woody’s Pet Food Deli RAW CORNISH HEN with SUPPLEMENTS (15 oz. plastic container). PLU Code 1652. Expiration date 11/20/22

Two (2) 5lb tubs were sold in the company’s St Paul store. Twelve (12) 15oz containers were distributed through its 3 Twin Cities, MN retail stores.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms.

Consumers exhibiting these signs after having contact with this product should contact their healthcare providers. Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The company continues their investigation as to the source of the problem and will resume production when the problem is resolved. The recall is a result of FDA sampling due to a consumer complaint on another product, which testing revealed a sample of this product contains Salmonella.

Consumers who have these products should discontinue use and may return the unused portion to the place of purchase for a full refund. If you have recalled product in your home, clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Because animals can shed the bacteria in the feces when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home. Consumers should thoroughly wash their hands after handling the affected product or cleaning up potentially contaminated items and surfaces.

Company name: Woody’s Pet Food Deli
Brand name: Woody's Pet Food Deli
Product recalled: Raw Cornish Hen pet food “With Supplements”
Reason of the recall: Potential Salmonella
FDA Recall date: December 23, 2021

Check the full recall details on fda.gov

Source: FDA
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The Procter & Gamble Company issued a voluntary product recall to the consumer level of aerosol dry conditioner spray products and aerosol dry shampoo spray products from Pantene, Aussie, Herbal Essences, and Waterless produced in the United States, in addition to previously discontinued aerosol dry shampoo products... See More from Old Spice and Hair Food, due to the presence of benzene detected in some products.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening.

Based on exposure modeling and the cancer risk assessments published by the Environmental Protection Agency (EPA) (IRIS database), daily exposure to benzene in the recalled products at the levels detected in our testing would not be expected to cause adverse health consequences. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

To date, The Procter & Gamble Company has not received any reports of adverse events related to this recall and is conducting this recall out of an abundance of caution. Detailed instructions for how to request a reimbursement for eligible products can be found below. The affected products are packaged in aerosol cans.

See the table in the link below for images, product names, UPC and production code ranges. Refer to the image attached for guidance on where to find the production code details on the bottom of the can. The first four numbers of the production code are the only ones necessary to determine if your product is impacted and falls within the ranges outlined. The aerosol dry conditioner spray products impacted are listed in the link below.

Following recent reports that indicated traces of benzene in some aerosol spray products, we began a review of our total portfolio of aerosol products. While benzene is not an ingredient in any of our products, our review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. We detected benzene in aerosol dry shampoo spray products and aerosol dry conditioner spray products. Nothing is more important to us than the safety of the consumers who use our products and the quality of the products we ship.

No other products from Pantene, Aussie, Herbal Essences, Hair Food, and Waterless are in the scope of this recall and such other products may continue to be used as intended, including those aerosol dry shampoo spray products with production code ranges different from those specifically communicated. The vast majority of our products are not part of this recall, including mousses, hairsprays, liquid shampoos, liquid conditioners, styling products, treatments, and unaffected aerosol dry shampoo sprays.

The recalled products were distributed nationwide in the United States through retail outlets and online. Retailers have been alerted to remove recalled products from shelves. Our brands will also offer reimbursement for consumers who have purchased products impacted by this recall. Consumers should stop using and appropriately discard the affected aerosol dry conditioner spray products and aerosol dry shampoo spray products.

Check the full recall details on fda.gov

Company name: The Procter & Gamble Company
Brand name: Pantene, Aussie, Herbal Essences, Waterless
Product recalled: aerosol dry conditioner spray products and aerosol dry shampoo spray products
Reason of the recall: Due to the presence of benzene detected
FDA Recall date: December 17, 2021

Source: FDA
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Monkfield Nutrition is extending the recall to all batches of frozen feeder mice products for feeding reptiles because Salmonella has been found in the products.

- Mouse Pinkies Small (25 pack (1g per mouse))
- Mouse Pinkies Large (25 pack (2-3g per mouse))
- ‘Pets at Home’... See More Mouse Fluff (Individual and 20 pack (3-5g per mouse))
- ‘Pets at Home’ Small Mice (Individual and 20 pack (10-15g per mouse))
- ‘Pets at Home’ Medium Mice (Individual and 20 pack (16-20g per mouse))
- ‘Pets at Home’ Large Mice (Individual and 20 pack (21-30g per mouse))
- ‘Pets at Home’ X Large Mouse (Individual and 15 pack (>31g per mouse))
- Mouse Fluff (25 pack (4-6g per mouse))
- Mouse Crawlers Small (25 pack (7-9g per mouse))
- Small Mice (10 pack (10-15g per mouse))
- Medium Mice (10 pack (16-20g per mouse))
- Large Mice (10 pack (21-30g per mouse))
- Jumbo Mice (10 pack (>31g per mouse))
- ‘Pets at Home’ Mouse Pinkies Small (Individual, 20 pack and 100 pack (1g per mouse))
- ‘Pets at Home’ Mouse Pinkies Large (Individual, 20 pack and 100 pack (2-3g per mouse))

(pet owners): 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.

When handling and serving pet feed it is always advised to clean utensils after use. Consumers should wash hands thoroughly after handling reptiles, pet feed, utensils or after contact with the faeces of animals. Raw pet feed should be stored separately from any food (especially ready to eat foods). Care should be taken when defrosting to avoid cross contamination of foods and surfaces.
Carefully and thoroughly clean and disinfect any surfaces it has been in contact with, including your hands.

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

In humans, symptoms caused by salmonella usually include fever, diarrhoea and abdominal cramps. Infected animals may not necessarily display signs of illness, but symptoms can include diarrhoea.

Company name: Monkfield Nutrition
Product recalled: Mouse Pinkies Small, Mouse Pinkies Large, ‘Pets at Home’ Mouse Fluff, ‘Pets at Home’ Small Mice, ‘Pets at Home’ Medium Mice, ‘Pets at Home’ Large Mice, ‘Pets at Home’ X Large Mouse, Mouse Fluff, Mouse Crawlers Small, Small Mice, Medium Mice, Large Mice, Jumbo Mice, ‘Pets at Home’ Mouse Pinkies Small, ‘Pets at Home’ Mouse Pinkies Large
FSA Recall date: 12/10/2021

Check the full recall details on food.gov.uk

Source: FSA
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