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Updated: September 23, 2020 9:00 AM
Artopolis Bakery, Cafe & Agora, S Halsted St, Chicago, IL, USA, Artopolis Bakery, Cafe & Agora, S Halsted St, Chicago, IL, USA
Artopolis Bakery, Cafe & Agora, S Halsted St, Chicago, IL, USA
September 23, 2020 9:00 AM
“Report date: Sep 17, 2020
2. City of chicago food service sanitation certificate
- comments: observed no city of chicago certified food manager on site during time of inspection while preparing and serving cooked chicken, sliced tomatoes, potatoes,dairy creamer, leafy greens, salmon etc. Instruc... See Moreted to provide at least one certified manager on site at all times with valid original certificate posted for public view. Priority foundation violation. 7-38-012. Citation issued.
16. Food-contact surfaces: cleaned & sanitized
- comments: observed ice machine a little dirty inside. Instructed to clean and sanitize and maintain.
16. Food-contact surfaces: cleaned & sanitized
47. Food & non-food contact surfaces cleanable, properly designed, constructed & used
- comments: observed prep table shelves with excessive dried debris in bakery prep area in basement. Must clean and maintain.
55. Physical facilities installed, maintained & clean
- comments: observed pooling water on floor near ice machine. Must remove to prevent pest breeding site.
56. Adequate ventilation & lighting; designated areas used
- comments: observed burned out light bulbs in basement storage near liquor room. Instructed to replace and maintain adequate lighting.
58. Allergen training as required
- comments: observed no allergen training certificate on site for city of chicago certified food manager. Instructed to meet requirement and maintain on site for review.
Source: chicago.gov See Less”
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El Rinconcito De Morelos, 3910 W North Ave, Chicago, IL, USA, El Rinconcito De Morelos, 3910 W North Ave, Chicago, IL, USA
El Rinconcito De Morelos, 3910 W North Ave, Chicago, IL, USA
September 23, 2020 9:00 AM
“Report date: Sep 21, 2020
3. Management, food employee and conditional employee; knowledge, responsibilities and reporting
- comments: observed no signed employee health policy on the premises. Management instructed to have a signed employee health policy for each employee. Priority foundation 7... See More-38-010. Citation issued.
5. Procedures for responding to vomiting and diarrheal events
- comments: observed no clean up supplies on the premises to respond to vomit and diarrheal events. Management instructed to provide all items listed on the clean up procedure. Priority foundation 7-38-005. Citation issued.
25. Consumer advisory provided for raw/undercooked food
- comments: observed no consumer advisory disclosure and reminder statement on the menu for raw or undercooked foods. Management instructed to disclose and describe which foods can be ordered raw or undercooked and link those items to a reminder statement on the menu. Priority foundation 7-38-005. Citation issued.
38. Insects, rodents, & animals not present
- comments: observed evidence of rodent activity on the premises and live flies and insects on the premises. Observed 20 rat droppings on the floor in the basement under the staircase and around the mop sink. Management instructed to clean and remove all rodent droppings. Also observed 1 live cockroach on the floor behind the 2 door prep cooler. Also observed approximately 15 live small flies and 5 house flies in the dining room and food prep area. Additional pest control service is needed to eliminate the pest activity. Priority foundation 7-38-020(a). Citation issued.
49. Non-food/food contact surfaces clean
- comments: clean the grease on the exterior of the grease trap and the food debris inside of the microwave.
53. Toilet facilities: properly constructed, supplied, & cleaned
- comments: no covered waste receptacle was provided in the women's washroom. Must provide.
53. Toilet facilities: properly constructed, supplied, & cleaned
- comments: the women's washroom door lacks a self-closing door device. Management instructed to install.
55. Physical facilities installed, maintained & clean
- comments: clean the food debris on the walls of the food prep area.
56. Adequate ventilation & lighting; designated areas used
- comments: the ventilation fan in the men's washroom is not operational. Management instructed to repair or replace the ventilation fan.
56. Adequate ventilation & lighting; designated areas used
- comments: observed excessive grease on the ventilation hood and filters. Management instructed to clean and maintain.
Source: chicago.gov See Less”
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Somer Food Market, 2812 W Devon Ave, Chicago, IL, USA, Somer Food Market, 2812 W Devon Ave, Chicago, IL, USA
Somer Food Market, 2812 W Devon Ave, Chicago, IL, USA
September 23, 2020 9:00 AM
“Report date: Sep 17, 2020
2. City of chicago food service sanitation certificate
- comments: observed no valid city of chicago food sanitation certificate posted on the premises. Management instructed that a certified food manager must be present at all times while tcs foods are being prepared a... See Morend served. Priority foundation 7-38-012. Citation issued.
11. Food obtained from approved source
- comments: observed food stored in the walk-in cooler from an unapproved source. Observed 20 packages of cream kajmak spread manufactured from george's food stored in a plastic container inside of the walk-in cooler. No invoice was provided for the packaged food. A held for inspection tag was placed on the container of food. Management instructed not to sell this product. Priority 7-38-005. Citation issued.
37. Food properly labeled; original container
- comments: observed prepackaged foods such as cheeses, breads, and candies not labeled to indicate the name and address of the manufacturer, net contents, ingredients, or weight. Management instructed to label all prepackaged foods.
38. Insects, rodents, & animals not present
- comments: observed evidence of rodent activity on the premises. Observed approximately 100 mouse droppings on the floor and on the food storage shelves in the retail display area, rear storage rooms and in the utility room next to the 3 compartment sink. Management instructed to clean and remove all rodent droppings from all affected areas. Additional pest control service is needed to eliminate the pest activity. Priority foundation 7-38-020(a). Citation issued.
54. Garbage & refuse properly disposed; facilities maintained
- comments: observed garbage overflowing over the top of the garbage dumpsters so that the dumpster lids could not be closed. Management instructed to provide adequate garbage pickup so that the garbage does not overflow over the top of the garbage dumpsters. Also remove all old tires stored behind the dumpsters. Priority foundation 7-38-020(b). Citation issued.
55. Physical facilities installed, maintained & clean
- comments: clean the floor throughout the premises especially underneath the food storage shelves.
64. Public health nuisance
- comments: observed no social distancing by customers while waiting in line to check out at the register. Observed 6 customers standing in line less than 6 feet apart from each other. Management instructed to ensure that all customers practice social distancing while shopping inside of the store. Citation issued 7-28-060.
Source: chicago.gov See Less”
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El Taconazo Restaurant - El Original #1, 4124 W North Ave, Chicago, IL, USA, El Taconazo Restaurant - El Original #1, 4124 W North Ave, Chicago, IL, USA
El Taconazo Restaurant - El Original #1, 4124 W North Ave, Chicago, IL, USA
September 23, 2020 9:00 AM
“Report date: Sep 21, 2020
10. Adequate handwashing sinks properly supplied and accessible
- comments: obsreved no soap at hand sink in front prep/cooking area. Instructed must provide hand washing cleanser at all hand sinks at all times. Operator provided during inspection. Priority foundation v... See Moreiolation 7-38-030(c). Citation issued.
10. Adequate handwashing sinks properly supplied and accessible
- comments: observed no paper towels at hand sink in front prep/cooking area, and at hand sink in rear prep area. Must provide sanitary means to dry hands at all hand sinks at all times. Priority foundation volation 7-38-030(c). See above violation 6-301. 11 for citation.
22. Proper cold holding temperatures
- comments: observed tcs foods at improper temperatures in prep cooler in front cooking area. Found beef @ 47. 4f, eggs @ 58. 1f; chicken @ 44. 9; shreded cheese @ 49. 3f; chili rellenos @ 46. 9; cooked vegetables and peppers @ 49. 2f; pork @ 47. 4f ham @ 48. 0f; and pork @ 54. 4f. Instructed must keep all tcs foods @ 41f or less at all times when in refrigeration. Operator voluntarily discarded 40lbs of denature foods during inspection. Operator estimates value to be approximately $200. Priority foundation violation 7-38-005. Citation issued.
23. Proper date marking and disposition
- comments: observed no lables on prepped tcs foods inside coolers and walk in coolers. Must properly label all prepped tcs foods with discard date no more than 7 day from preparation date. Must correct and maintain same. Priority foundation violation 7-38-005. Citation issued.
33. Proper cooling methods used; adequate equipment for temperature control
- comments: found prep cooler not able to maintain proper temperature in front cooking/prep area. Ambient air temperature inside prep cooler @ 50. 0f. Instructed must have ambient air temperature of 41f or less inside all refrigeration. All tcs foods discarded and cooler tagged and held for inspection. Priority violation 7-38-005. Citation issued.
38. Insects, rodents, & animals not present
- comments: found approximately 30 mice droppings on shelves and on floors in basement near stairs. Instructed must eliminate pest issue, must clean and sanitize affected areas. Priority foundation violation 7-38-020(a). Citation issued.
41. Wiping cloths: properly used & stored
- comments: observed used wiping cloths on counters throughout prep areas. Must keep all wiping cloths inside sanitation solution when not in use.
49. Non-food/food contact surfaces clean
- comments: observed excessive grease accumulation on lower interior of fryer. Must detail clean and sanitize. Must maintain same.
55. Physical facilities installed, maintained & clean
- comments: observed cardboard used under matts throughout prep areas. Must remove. All sufraces must be smooth, easily cleanable and nonporous.
Source: chicago.gov See Less”
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Tacos & Tamales, 5714 W Fullerton Ave, Chicago, IL, USA, Magos Tacos & Tamales, 5714 W Fullerton Ave, Chicago, IL, USA
Magos Tacos & Tamales, 5714 W Fullerton Ave, Chicago, IL, USA
September 23, 2020 9:00 AM
“Report date: Sep 21, 2020
2. City of chicago food service sanitation certificate
- comments: observed no city of chicago certified food manager on site during this inspection while (tcs foods) pork etc. Has been prepared and served. Instructed a city of chicago certified food manager must be on... See Moresite at all times while (tcs foods) are being prepared and served. Priority foundation violation 7-38-012, citation issued.
16. Food-contact surfaces: cleaned & sanitized
- comments: observed a slight debris accumulation on the interior of the ice machine. Must remove debris, detail clean inside ice machine and maintain ice machine at all times.
37. Food properly labeled; original container
- comments: instructed to provide labels for bulk food containers/bins identified with common name (salt, sugar, flour etc).
47. Food & non-food contact surfaces cleanable, properly designed, constructed & used
- comments: observed a torn door gasket inside of the rear 2 door stand-up freezer. Management instructed to replace the torn door gasket.
49. Non-food/food contact surfaces clean
- comments: instructed to detail clean excessive grease build-up on pipes behind cooking equipments and maintain.
51. Plumbing installed; proper backflow devices
- comments: observed water leaks at base of faucet 3-compartment sink. Must repair plumbing leaks and to maintain.
55. Physical facilities installed, maintained & clean
- comments: instructed to replace broken (floor tiles) in front of the 3-compartment sink area.
55. Physical facilities installed, maintained & clean
- comments: instructed to detail clean and organize rear dry storage area and remove unnecessary articles/milk crates due to potential pest harborage.
56. Adequate ventilation & lighting; designated areas used
- comments: instructed to detail clean and maintain kitchen exhaust hood/filters to remove accumulation of grease build-up.
60. Previous core violation corrected
- comments: previous core violation not corrected from inspection report#2352251 dated:11/25/2019 58 2-102. 13 observed the certified food manager without an allergen training certificate. Management instructed that all certified food managers must show proof of training. 02/18/2020 instructed manager to comply with food allergen training and maintain. Priority foundation violation 7-42-090,citation issued.
Source: chicago.gov See Less”
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Golden Dragon, 2459 W Madison St, Chicago, IL, USA, Golden Dragon, 2459 W Madison St, Chicago, IL, USA
Golden Dragon, 2459 W Madison St, Chicago, IL, USA
September 23, 2020 9:00 AM
“Report date: Sep 17, 2020
10. Adequate handwashing sinks properly supplied and accessible
- comments: observed hand-sink in prep area without hand cleanser available for proper hand washing during time of inspection. Instructed to provide and maintain at all times. Priority foundation violation.... See More7-38-030 (c). Citation issued.
10. Adequate handwashing sinks properly supplied and accessible
- comments: observed no hand drying provision available at two handsinks located in (in use) prep area as well as toilet room during time of inspection. Must provide and maintain. Priority foundation violation. 7-38-030 (c). See previous violation for citation.
22. Proper cold holding temperatures
- comments: observed the following time/temperature control for safety food items stored in upright refrigeration unit in prep area at improper cold holding temperatures during time of inspection. They are as follows. . . 5 lbs of cooked beef @163. 0f and 2 lbs of additional beef chunks @ 53. 5f. Instructed to hold all cold held items @ 41f or below at all times and maintain. Manager voluntarily discarded during this time. Priority violation. 7-38-005. Citation issued.
23. Proper date marking and disposition
- comments: observed the following time/temperature control for safety foods stored in cooling units throughout facility without any labels. . . Egg rolls,fried chicken, cooked beef and chicken, marinated chicken/shrimp, and cooked noodles. Instructed to provide discard or use by dates not to exceed 7 days on all food items refrigerated, ready to eat items stored on site for more than 24 hours. Must maintain. Priority foundation violation. 7-38-005. No citation issued.
36. Thermometers provided & accurate
- comments: observed no thermometers inside of both upright refrigeration units located in prep area to to measure internal temperatures. Instructed to provide and maintain.
37. Food properly labeled; original container
- comments: observed working ingredients located at wok without any labels. Must provide common name labels for herbs and spices.
40. Personal cleanliness
- comments: observed dirty aprons worn by all food handlers. Instructed to provide clean outer clothing to wear while open and operating and handling food. Must maintain.
41. Wiping cloths: properly used & stored
- comments: observed soiled wiping cloths stored throughout prep area on tables and hanging on sinks improperly drying. Instructed to store inside sanitizing buckets with chlorine @ at least 50 ppm. Must maintain.
47. Food & non-food contact surfaces cleanable, properly designed, constructed & used
- comments: observed grocery bags used for storage. Instructed to discontinue use and provide food grade storage bags only for food storage. Must maintain.
48. Warewashing facilities: installed, maintained & used; test strips
- comments: observed no chemical test strip kit on site to match available sanitizer (chlorine bleach) for proper sanitizing of equipment/utensils at 3 compartment sink. Instructed to provide and maintain chlorine test strips at all times. Priority foundation violation. 7-38-005. Citation issued.
57. All food employees have food handler training
- comments: observed no food handler training certificates on site for review. Instructed to meet requirements.
58. Allergen training as required
- comments: observed no allergen training for new city of chicago certified food manager on site. Instructed to meet requirement and maintain on site for review.
Source: chicago.gov See Less”
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Kuma's Corner, 2900 W Belmont Ave, Chicago, IL, USA, Kuma's Corner, 2900 W Belmont Ave, Chicago, IL, USA
Kuma's Corner, 2900 W Belmont Ave, Chicago, IL, USA
September 22, 2020 9:00 AM
“Report date: Sep 16, 2020
55. Physical facilities installed, maintained & clean
- comments: the following areas throughout the basement must have a smooth cleanable ceiling without open gaps, crevices: above the utility mop sink, hallways leading to both walk-in coolers, hallway leading to rear... See Morebasement exit, far rear storage area.
58. Allergen training as required
- comments: the above pending city of chicago certified food manager must obtain allergen training.
Source: chicago.gov See Less”
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Sharks Fish & Tony's Steak, 805 W 111th St, Chicago, IL, USA, Sharks Fish & Tony's Steak, 805 W 111th St, Chicago, IL, USA
Sharks Fish & Tony's Steak, 805 W 111th St, Chicago, IL, USA
September 22, 2020 9:00 AM
“Report date: Sep 17, 2020
2. City of chicago food service sanitation certificate
- comments: observed no valid city of chicago food sanitation certificate posted for manager on duty when tcs foods prepared and served. Priority foundation citation issued 7-38-012
3. Management, food employee... See Moreand conditional employee; knowledge, responsibilities and reporting
- comments: observed no employee health policy available. Instructed manager to provide employee health policy. Priority foundation
5. Procedures for responding to vomiting and diarrheal events
- comments: repeat -observed no procedures or supplies for responding to vomiting and diarrheal events. Instructed manager to provide clean up policy and all necessary supplies including disposable mop. Priority foundation issued 7-38-005
22. Proper cold holding temperatures
- comments: observed approx 25lbs of, cooked fried chicken inside large pan stored on shelving unit in rear prep area at improper cold temperature of 53. 0f. Instructed to maintain cold foods at 41. 0f or below inside cooler. Food was removed and discarded by manager at cost approx $ 60. 00. Priority violation issued 7-38-005
55. Physical facilities installed, maintained & clean
Source: chicago.gov See Less”
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Little Victories, 1725 W Division St, Chicago, IL, USA, Little Victories, 1725 W Division St, Chicago, IL, USA
Little Victories, 1725 W Division St, Chicago, IL, USA
September 22, 2020 9:00 AM
“Report date: Sep 18, 2020
10. Adequate handwashing sinks properly supplied and accessible
- comments: no hands washing signs in resttrooms, instructed to install.
40. Personal cleanliness
- comments: food handler with long beard not wearing beard restraints. Instructed to wear.
43. I... See Moren-use utensils: properly stored
- comments: spoons in use stored in stagnate water, instructed to keep in a dry clean container.
Source: chicago.gov See Less”
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Cook Elementary School, 8150 S Bishop St, Chicago, IL, USA, Cook Elementary School, 8150 S Bishop St, Chicago, IL, USA
Cook Elementary School, 8150 S Bishop St, Chicago, IL, USA
September 22, 2020 9:00 AM
“Report date: Sep 17, 2020
38. Insects, rodents, & animals not present
- comments: observed evidence of appx. 100 or more mice droppings on floor hot holding unit,at motor of cold holding unit,behind reach in freezer #2 ,under 3- compartment sink,locker room,under paper goods storage shelves,unde... See Morer equipment motors,next to walk in cooler,under dish machine,office area next to file cabinets. Must remove droppings. Clean and sanitize areas. Recommended to have a pest control operator to service premises on or after 9/17/20. (priority foundation 7-38-020(a)
44. Utensils, equipment & linens: properly stored, dried, & handled
- comments: must invert multi-use utensils on dish storage shelves.
47. Food & non-food contact surfaces cleanable, properly designed, constructed & used
- comments: must repair or replace loose compressor unit pan in walk in freezer.
50. Hot & cold water available; adequate pressure
- comments: observed no hot running water at hand sinks in 1st fl. Boy's (71. 1f) and 2nd fl. Girl's (84. 0f) toilet rooms in main north building. Must provide hot water at 100. 0f and maintain. (priority 7-38-030(c)
55. Physical facilities installed, maintained & clean
- comments: must repair or replace loose & damaged floor tile in front of 3- comp sink,holes in corners in dry food storage area,loose wall bases,damaged floor tiles & stained ceiling tiles in lunch room.
55. Physical facilities installed, maintained & clean
- comments: must remove ice build up from floor in walk in freezer.
56. Adequate ventilation & lighting; designated areas used
- comments: must repair or replace cracked light shield on serving line & prep area. Burnt out lights at hood of cooking equipment.
Source: chicago.gov See Less”
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Recent Interesting Reports
September 20, 2020 9:38 PM
“The CFIA announced the recall of PC Blue Menu brand Artichoke & Asiago Dip by Loblaw Companies Limited from the marketplace due it may contain egg which is not declared on the label. There have been no reported illnesses associated with the consumption of this product.
CFIA advises consumers not... See Moreto eat the recalled products and return them to the place of purchase for a full refund. The products were distributed nationwide.
- PC Blue Menu Artichoke & Asiago Dip (on lid) (side label states Tzatziki Yogurt Dip). Size: 227 g. UPC: 0 60383 03697 3. Codes: 2020 OC 31.
Check the full recall details on the CFIA website inspection.gc.ca
Source: CFIA See Less”
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Ready-To-Eat Chicken Salad Products -recalled due to Misbranding and an Undeclared Allergen, USA
USA
September 16, 2020 9:38 PM
“The FSIS announced the recall of approximately 6,890 pounds of ready-to-eat (RTE) chicken salad products by Willow Tree Poultry Farm, Inc due to misbranding and an undeclared allergen. The products may contain walnuts, a known allergen, which are not declared on the product labels. There have been n... See Moreo confirmed reports of adverse reactions due to consumption of these products to date.
FSIS advises consumers not to eat the recalled products and to throw them away or return them to the place of purchase. The RTE chicken salad product labeled as “Classic Chicken Salad” may actually contain “White Meat Cranberry Walnut Chicken Salad” and was produced on Sept. 2, 2020. The products subject to recall bear establishment number “EST. P-8827” inside the USDA mark of inspection. These items were shipped to retail locations in Connecticut, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, Rhode Island, Vermont and Virginia. The following products are subject to recall:
- 15-oz. clear, plastic containers labeled as “Willow Tree Premium White Meat CHICKEN SALAD Classic” with a sell by date of “9/30/20” and a time stamp of 13:00:00 through 17:00:00 on the containers’ cellophane lid.
Check the full recall details on the FSIS website fsis.usda.gov
Source: FSIS See Less”
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September 2, 2020 8:00 PM
“Company name: Sunshine Mills, Inc.
Brand name: Family Pet, Heartland Farms, Paws Happy Life
Product recalled: Dog Food
Reason of the recall: Elevated levels of aflatoxin
FDA Recall date: September 02, 2020
Recall details: Sunshine Mills, Inc. is issuing a voluntary recall of certain dog food pr... See Moreoducts due to levels of Aflatoxin that are potentially above the acceptable limit. Aflatoxin is a naturally occurring mold by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities. The potential for aflatoxin levels above the acceptable limit in these products was discovered by routine sampling performed by the Louisiana Department of Agriculture and Forestry showing that a sample of a single 4-pound bag of one lot of the product contained elevated levels of aflatoxin.
No illnesses have been reported in association with these products to date, and no other Sunshine Mills, Inc. pet food products are affected by this announcement. While no adverse health effects related to these products have been reported, Sunshine Mills, Inc. has chosen to issue a voluntary recall of these products as a precautionary measure in furtherance of its commitment to the safety and quality of its products.
Pets that have consumed any of the recalled products and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian. The affected products were distributed in retail stores nationally. Retailers who received the recalled lots have been contacted and asked to pull these lots from their inventory and shelves.
There are no other Family Pet®, Heartland Farms®, or Paws Happy Life® products or other lot codes of these products affected by this precautionary recall. Consumers who have purchased the recalled products should discontinue use of the product and may return the unused portion to the place of purchase for a full refund.
Consumers may contact Sunshine Mills, Inc. Customer Service at (800) 705-2111 from 7AM to 4PM Central Time, Monday through Friday, or by email at customer.service@sunshinemills.com for additional information. This is a voluntary recall being conducted in cooperation with the U.S. Food and Drug Administration. Products affected by this announcement:
+ Family Pet® Meaty Cuts Beef Chicken & Cheese Flavors Premium Dog Food.
- UPC: 3225120694. Size: 4 Lb. Lot codes: TD3 4/April/2020 | TD1 5/April/2020.
- UPC: 3225118078. Size: 14 Lb. Lot codes: TB1 4/April/2020 | TB2 4/April/2020 | TB3 3/April/2020
- UPC: 3225120694. Size: 28 Lb. TB3 3/April/2020
+ Heartland Farms® Grilled Favorites. Beef Chicken & Cheese Flavor.
- UPC: 7015514299. Size: 14 Lb. Lot codes: TB1 4/April/2020 | TB2 4/April/2020
- UPC: 7015514301 Size: 31 Lb. Lot codes: TA2 4/April/2020 | TA3 4/April/2020
+ Paws Happy Life® Butcher’s Choice Dog Food
- UPC: 3680035763. Size: 16 Lb. Lot codes: TA1 4/April/2020 | TA2 4/April/2020
Check the full recall details on fda.gov
Source: FDA See Less”
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September 7, 2020 8:36 PM
“The CFIA announced the recall of Frank brand Milk Chocolate Covered Raisins by Canadian Tire Corporation of Canada from the marketplace due to undeclared peanut.
- Frank Milk Chocolate Covered Raisins (300 g). UPC: 6 26394 33920 7. Best Before 2021 MA 07, Lot: 07EUA | Best Before 2021 MA 13, Lot... See More: 13EUA | Best Before 2021 JL 07, Lot: 07GUB | Best Before 2021 APR 21, Lot: 21DUB | Best Before 2021 JL 08, Lot: 08GUB
Check the full recall details on the CFIA website: inspection.gc.ca
Source: CFIA See Less”
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Leafree Hand sanitizer - recalled due to Product is labeled as edible alcohol., United States
United States
September 5, 2020 12:01 PM
“Company name: CorgioMed LLC
Brand name: Leafree
Product recalled: Hand sanitizer
Reason of the recall: Product is labeled as edible alcohol.
FDA Recall date: September 03, 2020
Recall details: CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within e... See Morexpiry to the consumer level. The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.
Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child.
Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. The labeling of this product as ‘edible alcohol’ may promote this behavior. The product is used as a hand sanitizer and is packaged in 100 ml (UPC #6970495860325), 300 ml (UPC #69705860318) and 500 ml (UPC #6970495860301) bottles.
Product was distributed Nationwide via CorgioMed website. CorgioMed LLC is notifying its distributors and customers by email and is arranging for return or disposal of all recalled products. Distributors and Consumers with questions regarding this recall can contact CorgioMed LLC by emailing to: contact@corgiomed.comor phone: 301-978-3898 from September 1st to September 30th, 2020. 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. Complete and submit the report Online.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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 See Less”
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September 1, 2020 4:36 PM
“Fresco Foods Inc. of Tampa, FL is voluntarily recalling ALL units of Ancient Grain Jackfruit Bowl sold at Publix because it may contain an undeclared allergen, FISH (anchovies). People who have an allergy or severe sensitivity to FISH (anchovies) run the risk of serious or life-threatening allergic... See Morereaction if they consume these products.
The allergy alert was initiated after it was discovered that the Ancient Grain Jackfruit Bowl containing Fish was distributed in packaging that did not reveal the presence of fish. Subsequent investigation indicates the problem was caused by sourcing the wrong sub-ingredient.
- Eat Fresco Ancient Grain Jackfruit Bowl. GTIN: 85898800510. Lot/Exp. Date: ALL
Individuals with an allergy or sensitivity to fish (anchovies) should not consume this product. Households that include individuals with an allergy or sensitivity to fish (anchovies) should dispose of the product or return it to the place of purchase for a refund.
Consumers with questions may contact Fresco Foods, Inc. at (813) 551-2100.
Check the full recall details on corporate.publix.com
Source: Publix See Less”
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September 2, 2020 11:41 PM
“The FSA announced the recall of Lamb and Carrot Dumplings by Freshasia Foods because they contain crustaceans, which are not mentioned on the label. This means the product is a possible health risk for anyone with an allergy to crustaceans.
FSA advises consumers not to eat the recalled product. I... See Morenstead, return it to the store from where it was bought for a full refund.
+ Freshasia Lamb and Carrot Dumplings. 400g. Batch code: 200402. Best before: 6 April 2021
Freshasia Foods is recalling the above product from customers and has been advised to contact the relevant allergy support organisations, which will tell their members about the recall. The company has also issued a point-of-sale notice to its customers. These notices explain to customers why the product is being recalled and tell them what to do if they have bought the product.
Check the full recall details on food.gov.uk
Source: FSA See Less”
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August 31, 2020 4:00 PM
“Company name: Mylan N.V.
Brand name: Mylan
Product recalled: Tranexamic Acid and Amiodarone HCl injections
Reason of the recall: Vials potentially packaged in incorrect cartons
FDA Recall date: August 31, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan In... See Morestitutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials.
These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals. To date, Mylan has not received any reports of adverse events related to this recall.
Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety. If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function.
If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events. Amiodarone HCl Injection, USP is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled batch information is as follows:
NDC #: 67457-153-09
Material Description: Amiodarone HCl Injection, USP
Strength: 450 mg/9 mL
Carton Size: 10 x 9 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021
NDC #: 67457-197-10
Material Description: Tranexamic Acid Injection, USP
Strength: 1000 mg/10 mL
Carton Size: 10 x 10 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021
Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. Wholesalers and hospital/clinic pharmacies that have product which is being recalled should stop use/further distribution or dispensing.
Check the full recall details on fda.gov
Source: FDA See Less”
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September 11, 2020 4:00 PM
“Company name: Goodie Girl Tribeca LLC
Brand name: Goodie Girl
Product recalled: Goodie Girl GF Magical Animal Crackers
Reason of the recall: May Contain Undeclared Wheat
FDA Recall date: September 11, 2020
Recall details: Goodie Girl Tribeca LLC announced today it is voluntarily recalling 389... See Morecases of a single date code of 7 oz. Goodie Girl Magical Animal Crackers, with a “best by” date of Jan 11, 21A3, after learning that the product may contain undeclared wheat ingredients. People who have an allergy or severe sensitivity to wheat run the risk of allergic reaction if they consume the product contained in the recalled boxes. There has been an individual with a wheat allergy that was treated for a wheat allergen reaction.
This recall affects only 389 cases of the following product, which were distributed in retail stores nationwide:
- Description; Goodie Girl GF Magical Animal Crackers
UPC# 8-5598700395-3
Size; 7 Ounces
Best By Date; Jan 11, 2021
Distributed between 4/17/2020 – 5/7/2020
This recall does not apply to any other “best by” dates, sizes or varieties of Goodie Girl Tribeca LLC. This recall was initiated in cooperation with the FDA and the third-party co-packer that produced the product. Product with this particular “best by” date was shipped and distributed by Goodie Girl Tribeca to its customers' warehouses located in Virginia, Pennsylvania, Georgia, New Hampshire, California. Consumers seeking a refund or additional information may contact info@goodiegirl.com or call 201-941-2000 9am – 5pm est.
Check the full recall details on fda.gov
Source: FDA See Less”
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September 17, 2020 11:00 PM
“Company name: Acella Pharmaceuticals, LLC
Brand name: NP Thyroid 15 & NP Thyroid120
Product recalled: Thyroid Tablets
Reason of the recall: Sub Potency
FDA Recall date: September 17, 2020
Recall details: Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg... See MoreNP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates.
Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.
To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images. To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Additionally, consumers may be able to determine that their product is not impacted by the recall if the “use by,” “discard after,” or “expiration date” on their prescription bottle is on or after December 2020.
Product NDC Lot # Exp. Date
NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg) 42192-327-01 M327E19-1 October 2020
NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg) 42192-328-01 M328F19-3 November 2020
Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
Check the full recall details on fda.gov
Source: FDA See Less”
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