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Pretty Thai Sweat Chili Sauce - recalled due to May contain Pretty Thai Peanut Sauce, Paint Rock, TX, USA

September 10, 2020 9:00 PM

Paint Rock, 76866 Texas, United States

Company name: Pretty Thai
Brand name: Pretty Thai
Product recalled: Pretty Thai Sweat Chili Sauce
Reason of the recall: May contain Pretty Thai Peanut Sauce
FDA Recall date: September 10, 2020
Recall details: Company Announcement Pretty Thai of Austin, Texas, is recalling Pretty Thai Peanut Sauce that may have been mislabeled as Pretty Thai Sweet Chili Sauce. There is a risk that a person with an allergy or severe sensitivity to peanuts could unintentionally consume a product containing peanuts because of this error. No illnesses have been reported to date.

The product was distributed to H-E-B and Central Market stores in Texas from March 19, 2020 to September 8, 2020. The product is packaged in clear, cylindrical PET bottles with black flip-top caps and clear labels with white print. The recall is for Pretty Thai Peanut Sauce with the Lot Code 0772000123. A small number of the Pretty Thai Peanut Sauce bottles were discovered to have been mislabeled as Pretty Thai Sweet Chili Sauce. Pretty Thai Peanut Sauce is yellow or gold in color, while Pretty Thai Sweet Chili Sauce is dark red in color. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume the mislabeled product.

Pretty Thai and its manufacturer, Ponder Foods, have coordinated efforts with H-E-B to remove all of the affected product from the shelves and from distribution. Out of an abundance of caution, we are alerting consumers in Texas who may have purchased either Pretty Thai Peanut Sauce or Pretty Thai Sweet Chili Sauce to check any product for Lot Code 0772000123. For consumers with no peanut allergy, this Lot Code of Pretty Thai Peanut Sauce, as well as any Lot Code of Pretty Thai Sweet Chili Sauce are completely safe to consume. Product may be returned to H-E-B and/or Central Market for a full refund. Subsequent investigation indicates the problem was caused by a temporary breakdown in the manufacturer's production and packaging processes.

Consumers with questions may contact the Pretty Thai brand directly via email at info@ptfawg.com or via telephone at 512 981 6170. Consumers or retailers may also contact the manufacturer, Ponder Foods, via email at info@ponder-foods.com or via telephone at 469 914 0052 (M-F, 9:00am-5:00pm CDT). Attached below is a photo of the mislabeled product with the affected Lot Code.  

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User

Related Reports

November 19, 2020 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi USA
Product recalled: Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
Reason of the recall: Cross Contamination with Lidocaine
FDA Recall date: November 19, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling a singl... See Moree lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level. To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction. 

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.

- Dexmedetomidine HCl in 0.9%. Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. NDC Number: 63323-671-50. Product Code: 671050. Batch number: 6123925. Expiration Date: 03/2022. First Ship Date: 04/09/2020. Last Ship Date: 04/13/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

November 9, 2020 5:00 PM

“Company name: Lohxa, LLC
Brand name: Lohxa
Product recalled: Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free
Reason of the recall: May be contaminated with Burkholderia lata
FDA Recall date: November 09, 2020
Recall details: Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconat... See Moree Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Lohxa, LLC related to this recall.

The prescription oral rinse product, available through institutional use only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free is distributed in cases each containing 50 unit dose cups. Each case contains a colored label around the lid and body of the case.

The product can be identified by as shown in the images below. Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free was distributed to Nationwide to hospital pharmacies. Lohxa, LLC is notifying its direct customers by Fedex overnight mail, electronic mail, phone call and is arranging for return of all recalled products.

Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Consumers with questions regarding this recall can contact Lohxa, LLC by phone at 1-800-641-5564 or email info@lohxa.com on Monday-Friday from 8am-5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Affected products and lot numbers follow below:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free, 15 mL (NDC:70166-027-15) LOT/ EXP: T09101A/01/2021 |T08292A/02/2021 |T10011A/02/2021 |M10193A/03/2021 |T10223A/03/2021

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

November 3, 2020 10:00 AM

“Company name: Nostrum Laboratories
Brand name: Nostrum Laboratories
Product recalled: Metformin HCl Extended Release Tablets, USP 500 mg
Reason of the recall: NDMA exceeds acceptable daily intake limit
FDA Recall date: November 03, 2020
Recall details: Nostrum Laboratories, Inc. is voluntarily... See Morerecalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-055-01. The affected Metformin HCl Extended Release Tablets, USP 500 mg lots are listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM5”. Metformin HCl Extended Release Tablets, USP 500 mg was distributed Nationwide to wholesalers.

- Metformin HCl Extended Release Tablets, USP 500 mg. NDC: 29033-055-01 (center panel). Lot Numbers - Expiry Dates: MET100201 - 05/2022. MET100401 - 05/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended-Release Tablets, USP 500 mg which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 Monday through Friday from 8am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

November 2, 2020 4:00 PM

“Company name: Nostrum Laboratories
Brand name: Nostrum Laboratories
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: NDMA exceeds acceptable daily intake limit
FDA Recall date: November 02, 2020
Recall details: Kansas City, Missouri, Nostrum Laborator... See Moreies, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg was distributed Nationwide to wholesalers.

- Metformin HCl Extended Release Tablets, USP 750 mg. NDC: 29033-056-01. Lot Numbers: MET200101 05/2022 | MET200301 05/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended Release Tablets, USP 750 mg which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 28, 2020 10:00 PM

“Company name: Whole Foods Market
Brand name: Whole Foods Market
Product recalled: Macaroni and Cheese products
Reason of the recall: Undeclared egg
FDA Recall date: October 28, 2020
Recall details: Whole Foods Market is voluntarily recalling select prepared Macaroni & Cheese products from store... See Mores across five states because they contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

The affected products were sold at Whole Foods Market stores in Maryland, New Jersey, Pennsylvania, Virginia and Washington, D.C. The product was sold in plastic containers and in family-style meal kits with Whole Foods Market scale labels in the prepared foods department, available both hot and refrigerated. The product was also available from the chef’s case counter and from Whole Foods Market online and catering menus. The affected products can be identified by the following information. All affected product has been removed from store shelves. No allergic reactions have been reported to date.

- Macaroni & Cheese, chef’s case. Product Code (begins with) M: 286501. Best by 10/28/2020
- Macaroni & Cheese, packaged. Product Code (begins with) M: 263608. Best by 10/27/2020
- Macaroni & Cheese, online and catering. Product Code (begins with) M: 114449 | 109866. Best by 10/23/2020
- Rotisserie Chicken Meals with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 261596 | 261580 | 261590 | 261601 | 261608 | 261616. Best by 10/26/2020
- Fried Chicken Meal with Mac & Cheese, packaged. Product Code (begins with) M: 247257. Best by 10/25/2020
- Fried Chicken Meal with Mac & Cheese, packaged on hot bar. Product Code (begins with) M: 237444. Best by 10/24/2020
- Chicken Rustico Romano Chef Plate with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 241442. Best by 10/28/2020
- Chicken Breast Chef Plate with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 299430. Best by 10/28/2020
- BBQ Turkey Meatballs Chef Plate with Mac & Cheese and Green Beans, packaged. Product Code (begins with) M: 241464. Best by 10/28/2020
- Roasted Turkey Chef Plate with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 242019. Best by 10/28/2020

Customers who purchased this product at Whole Foods Market can bring a valid receipt into stores for a full refund. Consumers with additional questions can call 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 p.m. CST, Monday through Friday, or 8:00 a.m. and 6:00 p.m. Saturday through Sunday.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 14, 2020 9:00 PM

“Company name: Hadson Toko Trading Co., Inc.
Brand name: Eishindo
Product recalled: Jelly Cups
Reason of the recall: Product poses a choking hazard.
FDA Recall date: October 14, 2020
Recall details: HADSON (TOKO) TRADING CO., INC. OF MASPETH, NY is recalling its 28.2oz (800g) bags of EISHINDO MI... See MoreNI CUP JELLY (50 pcs) (迷你果凍杯(大)) due to the product being a potential choking hazard based off of its product size and consistency. Small jelly cups have previously been implicated in choking deaths of children.

The recalled jelly cups were distributed nationwide in retail food stores and are sold in large clear bags of 50 jelly cups. The UPC code is, “4970481000034,” Product code is, “E007.” No incidents of consumers choking have been reported to date in connection with this product. The potential choking hazard was noted after discussion with a representative from the Food and Drug Administration.

Consumers who have purchased 28.2oz (800g) bags of EISHINDO MINI CUP JELLYS are urged to return them to the store where they were purchased for a full refund or throw them away in a sealed package inside a secure garbage can with a tight fitting lid. Consumers who have questions or concerns may contact the company at 718-628-6761 Monday thru Friday between 8AM and 6PM EST.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 5, 2020 2:00 PM

“Company name: Marksans Pharma Limited
Brand name: Time-Cap Labs Inc.
Product recalled: Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 700 mg
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: October 05, 2020
Recall detai... See Morels: Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall. Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles with the following NDC#s in different packing configurations
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
- Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
100 counts: 49483-624-01

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side and Metformin Hydrochloride Extended-Release Tablets, USP 750mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750 mg were distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.

Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lots. Distributors //customers that have affected lots of Metformin Hydrochloride Extended- Release Tablets, USP 500mg & 750mg those are being recalled should return to place of purchase. The lot # can be located on the side panel of bottle labels as well as shipper/case labels.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.

Consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. Consumer 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.

Check the full recall details and list of products on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 23, 2020 3:00 PM

“Company name: Sun Pharmaceutical Industries
Brand name: Riomet ER
Product recalled: Metformin Hydrochloride for Extended-Release Oral Suspension
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: September 23, 2020
Recall details: Sun Pharmace... See Moreutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.  To date, SUN PHARMA has not received any reports of adverse events related to this recall.  RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.  RIOMET ER™, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle.  Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup.  The affected RIOMET ER™ is the following lot:

- RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL. Lot # AB06381. NDC #10631-019-17. Expiration Date: 10/2021. Number of Units: 747 cartons.

The product can be identified by the bottles or carton labeled as RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), containing the specific Lot Number and Expiration Date referenced above or on the labeling below. The product was distributed nationwide to wholesale customers.

SUN PHARMA is notifying its distributors and customers through its third-party Recall Coordinator (Inmar Inc.), via FedEx standard overnight shipping and will arrange for return of all recalled products.

Distributors and retailers that have RIOMET ER™ (metformin hydrochloride for extended release oral suspension), which is being recalled, should stop distributing and return it to place of purchase or as directed in the recall notification.

Patients taking RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at fda.gov

Consumers with questions regarding this recall can contact SUN PHARMA by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. 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.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 22, 2020 3:00 PM

“Company name: Real Pet Food Company
Brand name: Billy+Margot Wild Kangaroo and Superfoods Recipe
Product recalled: Dog food
Reason of the recall: Salmonella
FDA Recall date: September 22, 2020
Recall details: Real Pet Food Company is voluntarily recalling Billy+Margot Wild Kangaroo and Superfoo... See Moreds Recipe 4lb bags because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products. While no illnesses have been reported, 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.

Owners exhibiting any signs after having contact with this product should contact their healthcare provider. Pets with Salmonella infections may be lethargic and have diarrhea, fever, vomiting and or 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. Retailers who have received product from the affected lot code have been asked to remove this product from shelves immediately and dispose of the product carefully.

If you have purchased Billy+Margot Wild Kangaroo and Superfoods Recipe in a 4 lb bag, with lot code V 07 Feb 2022 from any retail store nationally, please stop feeding the product to your dogs, dispose of this product immediately, wash your hands accordingly, and sanitize affected surfaces. This recall does not affect any other Billy+Margot products or those sold outside of the USA. The recall is a result of a routine sampling program by state officials which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product.

The FDA and the company will continue their investigation as to what caused the problem. Consumers who have purchased the recalled products may call Real Pet Food between 8 am and 10 pm EST immediately for a refund or for additional information at : 1-800-467-5494. Consumers with questions may contact the company at : 1-800-467-5494 during the above times also.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 22, 2020 12:00 AM

“Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: BD Alaris System Hardware
Reason of the recall: Potential for four hardware situations that may result in the infusion pump not operating as expected
FDA Recall date: September 21, 2020
Recall details: Three Recall... See Mores Designated as Class I by FDA; One Designated as Class II BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on  previously announced voluntary recalls of the BD Alaris™ System. Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. This FDA classification does not change the guidance BD provided in the company’s Aug. 4th recall announcements to customers. BD initiated the voluntary recalls to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations.

The four recalls include:  Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits(Recall 1 – Class I):
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion, interruption of infusion or inability to titrate medication.

Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits(Recall 2 – Class I):
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion or interruption of infusion.

BD Alaris™ Syringe Module Model 8110 and PCA Module Model 8120(Recall 3 - Class I):
The Alaris PC unit may display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion or over-infusion.

BD Alaris™ EtCO2 Module model 8300 channel error(Recall 4 – Class II)
Infusion pump component defect may result in interruption of patient monitoring.

Customers should review and follow the instructions in each of the recall letters listed above. Affected Products:

- Recall 1:  BD Alaris™ PC Unit model 8015 (manufactured from April 7, 2017 to present)
PC Unit Front Case with Keypad Replacement Kits:
TC10008389  ASSY CASE FRONT W/KEYPAD 8015LS
TC10010217  ASSY FRT CASE W/ KEYPAD 8015 M2
TC10012515  ASSY FR CASE W/ KEYPAD 8015 M2
TC10013702  ASSY, CASE, FRONT W/KEYPAD, 8015LS
TC10013664  ASSY FR CASE W/ KEYPAD 8015 M2

- Recall 2:  BD Alaris™ Pump Module Model 8100 (manufactured from December 1, 2016 to January 23, 2019)
Pump Module Door Assembly Replacement Kits (labeled with a date prior to January 25, 2019)
Affected part numbers: 49000239; 49000346; 49000438; 49000439

- Recall 3: BD Alaris™ Syringe Module Model 8110 (manufactured from March 1, 2010 to present)
BD Alaris™ PCA Module Model 8120 (manufactured from March 1, 2010 to present)
Syringe/PCA Sizer Sensor Replacement Kit (manufactured from March 1, 2010 to present)
Affected part number: 12278652 

- Recall 4: Alaris™ EtCO2 Module, Model 8300 (manufactured from January 5, 2018 to January 4, 2019)

Note that some affected devices may be branded under the CareFusion name. Customer inquiries related to this action should be addressed to BD’s Recall Support Center at 888-562-6018 or SupportCenter@bd.com. FDA MedWatch Reporting Adverse reactions/events experienced with the use of either of these products should also be reported to the FDA's MedWatch Program.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Recent Interesting Reports

November 23, 2020 2:00 PM

“Company name: Fusion Health and Vitality LLC
Brand name: CORE, Immune Boost
Product recalled: CORE essential nutrients and Immune Boost Sublingual Vitamin D3
Reason of the recall: Unapproved new drug
FDA Recall date: November 23, 2020
Recall details: Fusion Health and Vitality LLCis voluntaril... See Morey recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws. Hordenine HCl is possibly unsafe when taken by mouth. Hordenine HCl might have similar stimulant effects and side effects such as rapid heart rate and high blood pressure.

Fusion Health and Vitality LLC has not received any reports of adverse events related to this recall.  Please review the attached photos for identification. We began shipping Core Essential Nutrients on 1/2/2020 and we began shipping Immune Boost Sublingual Vitamin D3 on 4/15/2020. Both products are packaged with labels which prominently display the product name.  CORE essential nutrients are found in a dark colored jar, in powdered format. 

This product was formulated to mix into a liquid before consumption. The Immune Boost sublingual was packaged in a 2 ounce bottle that came with a sublingual application dropper. Fusion Health and Vitality is notifying its customers by email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using it and return it to Fusion Health and Vitality for destruction. Consumers with questions regarding this recall or how to return recalled product can contact Fusion Health and Vitality by calling 1-888-964-5327, 9am to 5pm, Monday Thru Friday, EST. 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.

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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Reported By SafelyHQ.com User

November 19, 2020 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi USA
Product recalled: Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
Reason of the recall: Cross Contamination with Lidocaine
FDA Recall date: November 19, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling a singl... See Moree lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level. To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction. 

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.

- Dexmedetomidine HCl in 0.9%. Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. NDC Number: 63323-671-50. Product Code: 671050. Batch number: 6123925. Expiration Date: 03/2022. First Ship Date: 04/09/2020. Last Ship Date: 04/13/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

November 15, 2020 8:18 PM

“They are practically forcing people to put hand sanitizer on their hands even though they are not required to do so. I am allergic to some of the stuff because I don't know what's in their hand sanitizer and my hands got all cracked and chapped. They still practically forced people to do it even tho... See Moreugh there's no law. See Less
Reported By SafelyHQ.com User

They do not report positive COVID cases, In-N-Out Burger Distribution Center, Hamburger Lane, Baldwin Park, CA, USA

In-N-Out Burger Distribution Center, Hamburger Lane, Baldwin Park, CA, USA

October 31, 2020 12:15 AM

“I am a Butcher for the In N Out Meat Department in Baldwin Park. They do not report positive COVID cases. They just recently began social distance. Supervisor and managers and associates are covid positive or with symptoms. One associate has lost his sister to covid. He was never quarantined. In n o... See Moreut burger is responsible for a big part in the spread of the virus all across California. See Less
Reported By SafelyHQ.com User

November 9, 2020 5:00 PM

“Company name: Lohxa, LLC
Brand name: Lohxa
Product recalled: Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free
Reason of the recall: May be contaminated with Burkholderia lata
FDA Recall date: November 09, 2020
Recall details: Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconat... See Moree Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Lohxa, LLC related to this recall.

The prescription oral rinse product, available through institutional use only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free is distributed in cases each containing 50 unit dose cups. Each case contains a colored label around the lid and body of the case.

The product can be identified by as shown in the images below. Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free was distributed to Nationwide to hospital pharmacies. Lohxa, LLC is notifying its direct customers by Fedex overnight mail, electronic mail, phone call and is arranging for return of all recalled products.

Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Consumers with questions regarding this recall can contact Lohxa, LLC by phone at 1-800-641-5564 or email info@lohxa.com on Monday-Friday from 8am-5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Affected products and lot numbers follow below:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free, 15 mL (NDC:70166-027-15) LOT/ EXP: T09101A/01/2021 |T08292A/02/2021 |T10011A/02/2021 |M10193A/03/2021 |T10223A/03/2021

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 28, 2020 10:00 PM

“Company name: Whole Foods Market
Brand name: Whole Foods Market
Product recalled: Macaroni and Cheese products
Reason of the recall: Undeclared egg
FDA Recall date: October 28, 2020
Recall details: Whole Foods Market is voluntarily recalling select prepared Macaroni & Cheese products from store... See Mores across five states because they contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

The affected products were sold at Whole Foods Market stores in Maryland, New Jersey, Pennsylvania, Virginia and Washington, D.C. The product was sold in plastic containers and in family-style meal kits with Whole Foods Market scale labels in the prepared foods department, available both hot and refrigerated. The product was also available from the chef’s case counter and from Whole Foods Market online and catering menus. The affected products can be identified by the following information. All affected product has been removed from store shelves. No allergic reactions have been reported to date.

- Macaroni & Cheese, chef’s case. Product Code (begins with) M: 286501. Best by 10/28/2020
- Macaroni & Cheese, packaged. Product Code (begins with) M: 263608. Best by 10/27/2020
- Macaroni & Cheese, online and catering. Product Code (begins with) M: 114449 | 109866. Best by 10/23/2020
- Rotisserie Chicken Meals with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 261596 | 261580 | 261590 | 261601 | 261608 | 261616. Best by 10/26/2020
- Fried Chicken Meal with Mac & Cheese, packaged. Product Code (begins with) M: 247257. Best by 10/25/2020
- Fried Chicken Meal with Mac & Cheese, packaged on hot bar. Product Code (begins with) M: 237444. Best by 10/24/2020
- Chicken Rustico Romano Chef Plate with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 241442. Best by 10/28/2020
- Chicken Breast Chef Plate with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 299430. Best by 10/28/2020
- BBQ Turkey Meatballs Chef Plate with Mac & Cheese and Green Beans, packaged. Product Code (begins with) M: 241464. Best by 10/28/2020
- Roasted Turkey Chef Plate with Mac & Cheese and Broccoli, packaged. Product Code (begins with) M: 242019. Best by 10/28/2020

Customers who purchased this product at Whole Foods Market can bring a valid receipt into stores for a full refund. Consumers with additional questions can call 1-844-936-8255 between the hours of 7:00 a.m. and 10:00 p.m. CST, Monday through Friday, or 8:00 a.m. and 6:00 p.m. Saturday through Sunday.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Countryside Rehab, 205 Marine Dr, Anderson, IN 46016, USA

Countryside Rehab, 205 Marine Dr, Anderson, IN 46016, USA

November 10, 2020 12:00 PM

“Having covid positive employees work while still sick or they wont be paid, even though they got the virus from this facility. Employees are notified to come in to work if they test positive. If they don't have a fever they are told to work.


Source: Osha.gov | Receipt Date: 2020-09-29 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, PNC Bank, 1725 King Rd, Trenton, MI 48183, USA

PNC Bank, 1725 King Rd, Trenton, MI 48183, USA

November 10, 2020 12:00 PM

“1. 2 out of 8 employees are out from COVID 19. The company never let employees know they were exposed. 2. The offices have not been deep cleaned since 9/22/2020. 3. The customers they waited on in the offices have not been notified. 4. In the drive through employees are no more the 2 to 5 inches apa... See Morert. 5. Customers can come into the lobby which will not keep employees 6 ft from employees. 6. Staff have to share computers. 7. Employees are told as long as they wear a mask they are fine.


Source: Osha.gov | Receipt Date: 2020-09-25
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, United States Postal Service, San Jose Blvd, Carlsbad, NM 88220, USA

United States Postal Service, San Jose Blvd, Carlsbad, NM 88220, USA

November 10, 2020 12:00 PM

“Employer not following state, as well as CDC requirements and guidelines concerning Covid-19. Employer does not allow employees who have been in contact with some one who has tested positive to Covid-19 to quarantine as per CDC requirements.


Source: Osha.gov | Receipt Date: 2020-10-16 See Less
Reported By SafelyHQ.com User

November 3, 2020 12:00 PM

“Multiple employees(2) at EL SOMBRERO PATIO CAFE in LAS CRUCES, NM tested positive for Covid-19 and the company is on the Rapid Response COVID-19 Watchlist Event Date: 11/04/2020,

Source: env.nm.gov See Less
Reported By SafelyHQ.com User