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Riomet ER - recalled due to due to NDMA Impurity, USA

September 23, 2020 3:00 PM

United States

Riomet ER  - recalled due to due to NDMA Impurity, USA

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 Pharmaceutical 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

Reported By SafelyHQ.com User
More incidents from:
Drugs
Recall
United States

Related Reports

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

October 2, 2020 5:00 PM

“Company name: Ashtel Studios
Brand name: Smart Care
Product recalled: Hand sanitizer packaged in 0.84 oz. pouches
Reason of the recall: Product is packaged in containers resembling a food and drink pouch
FDA Recall date: October 02, 2020
Recall details: Company Announcement Ashtel Studios has a... See Morennounced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level.

The products are being recalled because they are packaged in containers resembling food and drink pouch. The recall does not affect any other Hand Sanitizer products from Ashtel Studios.

Product Size NDC
PAW Patrol Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-042-01
JoJo Siwa Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-044-01
Hot Wheels Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-045-01
Barbie Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-046-01
Trolls Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-047-01
Minions Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-043-01

Ingesting hand sanitizer, which is intended for topical use, could potentially 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. 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. Ashtel Studios has received no reports of adverse reactions.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 0.84 oz pouches. The product can be identified by examples of the products pictured below. Product was distributed to selected retailers in the United States and Canada.

Ashtel Studios has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

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

September 21, 2020 5:00 PM

“Company name: GHSW, LLC
Brand name: Trader Joe’s
Product recalled: Southwest Style Sweet Potato Saute Bowl
Reason of the recall: Undeclared milk and egg
FDA Recall date: September 21, 2020
Recall details: GHSW, LLC. is voluntarily recalling 1512 units of Trader Joe’s Southwest Style Sweet Pot... See Moreato Sauté Bowl due to undeclared milk and egg allergens in the dressing that are not declared on the label.  People who are allergic to milk and eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

The dressing is located in a pouch found inside the clear 21.5 oz. bowl. These bowls are sold in the refrigerated section of the store. The recalled product(s) were shipped to 36 Trader Joe’s stores in the following states:  AR, CO, KS, LA, NM, OK, TN, and TX. The recall has been isolated to only Southwest Style Sweet Potato Sauté Bowl with the Best By dates 09/23/20, 09/24/20, 09/25/20, 09/26/20, and 09/28/20 on the front of the package.

No other products or lots are affected by this recall. No reports of illnesses or injury have been received to date. The recall was initiated after it was discovered that the dressing containing milk and egg was distributed in packaging that did not declare the presence of milk or egg. GHSW, LLC is urging customers with any milk and egg allergy concerns to return the product to the point of purchase for a full refund or dispose of the recalled products.  GHSW is standing by to answer customer questions at 888-449-9386, M-F, 9 am to 4 pm PST.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 21, 2020 10:00 AM

“Company name: Homestead Creamer
Brand name: Homestead Creamery
Product recalled: Chocolate Ice Cream
Reason of the recall: Undeclared pecans
FDA Recall date: September 21, 2020
Recall details: Homestead Creamery of Wirtz, VA is recalling one lot of Homestead Creamery chocolate ice cream quarts,... See Moredated 5/13/2021, because it may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products. The chocolate ice cream quarts were distributed in Virginia and North Carolina in May through retail stores and direct delivery. The date of the ice cream is located on the bottom of the container.

No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that product containing the pecans may have been distributed in packaging that did not reveal the presence of pecans. Consumers should return the ice cream quart to the place of purchase for a full refund. Consumers with questions may contact the company at 540-721-2045.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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
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Reported By SafelyHQ.com User

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
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Reported By SafelyHQ.com User

October 22, 2020 7:00 PM

“Company name: COMERCIAL MEXICANA INNTERNATONAL INC
Brand name: TROPIQUE
Product recalled: ASSORTED FRUIT JELLY BAG & JELLY ANIMAL JAR
Reason of the recall: Potential Choking Hazard
FDA Recall date: October 22, 2020
Recall details: FDA Announcement Comercial Mexicana International Inc. in... See MoreBethpage New York is recalling the product because it may pose a choking hazard. Small jelly cups containing seaweed extract (carrageenan) has been identified as a potential choking hazard in children No incidents of consumers choking have been reported to date in connection with this problem. The potential choking hazard was discovered during a routine inspection by the New York State Department of Agriculture and Markets, Food Safety and inspection. The recalled jelly cups were sold in NY, NJ, CT, PA retail stores. The recall products are:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

Recent Interesting Reports

October 14, 2020 11:12 PM

“I bought a 4 pack of their Bakery Banana Nut Muffins. I've bought them before, so I didn't have any concerns. On opening my first one, the paper wrapper looked like it had worms on the bottom of it. I'd never seen that before, so I checked the bottom of the muffin, and that had some too. I've thrown... See Morethe rest away. As I said, I've bought these often and they've never had this, so this isn't normal. At this same location, I had gotten a pack of mini brownies in the flat plastic container and there were plastic pieces baked into the brownies. Had to throw those out too, after there were at least 5 with plastic chips in them. Clearly quality control has gone way down here. See Less
Reported By SafelyHQ.com User

October 9, 2020 12:00 AM

“Company name: Sunshine Mills, Inc.
Brand name:
Product recalled: Pet Food
Reason of the recall: May Contain Aflatoxin
FDA Recall date: October 08, 2020
Recall details: Company Announcement Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with c... See Moreorn that contained Aflatoxin at levels above FDA’s action levels. This is an expansion of the recall initiated September 2, 2020, after an investigation conducted along with the U.S. Food and Drug Administration determined that additional corn-based pet food products produced between April 3, 2020 and April 5, 2020 may contain corn from a single load of corn with elevated levels of aflatoxin. 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. 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.

Sunshine Mills, Inc. has chosen to expand its voluntary recall to include these additional products as a precautionary measure in furtherance of its commitment to the safety and quality of its products. Pets with aflatoxin toxicity (aflatoxicosis) may show symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, diarrhea, and in some cases, death. Pets experiencing any of these symptoms after consuming the recalled products should be seen by a veterinarian.

The affected products were distributed in retail stores within the United States. Principle Super Premium Natural Dog Food is exported exclusively to a distributor in Japan. Sportsman’s Pride Maintenance Adult Formula Dog Food is also exported to a distributor in Japan and Colombia. Retailers who received the recalled lots have been contacted and asked to pull any remaining inventory of these lots from their shelves. There are no other Champ®, Field Trial®, Good Dog, Hunter’s Special®, Old Glory®, Paws Happy Life®, Pet Expert, Principle, Retriever®, River Bend, Sportsman’s Pride®, Sprout®, Thrifty®, Top Runner® or Whiskers & Tails products or other lot codes of these products affected by this voluntary recall. The lot codes can be located on the back of each bag.

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. The expansion of this voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration. You can see the products affected by this announcement in the link below.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Unmasked employees, Wintrust Bank - Sauganash, West Peterson Avenue, Chicago, IL, USA

Wintrust Bank - Sauganash, West Peterson Avenue, Chicago, IL, USA

October 12, 2020 6:24 PM

“Walked in. Teller had mask on only over nose. She pulled it up as we approached. The other teller was masked, but this one was reckless and didn't care that co-workers and customers had to breathe in her disgusting breath? I asked a very simple account question and was told to talk to a personal ban... See Moreker. I turned to where she pointed and there sat an unmasked elderly female employee. As I approached her I said put on your mask. She replied that the little plastic partition was enough. I looked at her very shocked and she put on her mask. I refused to sit at her guest chair as it was within about 2 feet of her reckless, unmasked exhaling just moments before. She then immediately took pf her.mask, again putting her co-workers and me at risk, as well as anyone entering. Do they not know about aerosol spread? Needless to say we are closing both we have accounts there. See Less
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 2, 2020 5:00 PM

“Company name: Ashtel Studios
Brand name: Smart Care
Product recalled: Hand sanitizer packaged in 0.84 oz. pouches
Reason of the recall: Product is packaged in containers resembling a food and drink pouch
FDA Recall date: October 02, 2020
Recall details: Company Announcement Ashtel Studios has a... See Morennounced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level.

The products are being recalled because they are packaged in containers resembling food and drink pouch. The recall does not affect any other Hand Sanitizer products from Ashtel Studios.

Product Size NDC
PAW Patrol Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-042-01
JoJo Siwa Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-044-01
Hot Wheels Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-045-01
Barbie Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-046-01
Trolls Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-047-01
Minions Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-043-01

Ingesting hand sanitizer, which is intended for topical use, could potentially 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. 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. Ashtel Studios has received no reports of adverse reactions.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 0.84 oz pouches. The product can be identified by examples of the products pictured below. Product was distributed to selected retailers in the United States and Canada.

Ashtel Studios has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

October 22, 2020 7:00 PM

“Company name: COMERCIAL MEXICANA INNTERNATONAL INC
Brand name: TROPIQUE
Product recalled: ASSORTED FRUIT JELLY BAG & JELLY ANIMAL JAR
Reason of the recall: Potential Choking Hazard
FDA Recall date: October 22, 2020
Recall details: FDA Announcement Comercial Mexicana International Inc. in... See MoreBethpage New York is recalling the product because it may pose a choking hazard. Small jelly cups containing seaweed extract (carrageenan) has been identified as a potential choking hazard in children No incidents of consumers choking have been reported to date in connection with this problem. The potential choking hazard was discovered during a routine inspection by the New York State Department of Agriculture and Markets, Food Safety and inspection. The recalled jelly cups were sold in NY, NJ, CT, PA retail stores. The recall products are:
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 30, 2020 1:00 PM

“Company name: Estado de México, México, DMM VISSION, S.A. de C.V
Brand name: Cleaner
Product recalled: Cleaner Hand Sanitizer
Reason of the recall: Potential Presence of Methanol (Wood Alcohol)
FDA Recall date: September 30, 2020
Recall details: Company Announcement Estado de México, México, D... See MoreMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection of methanol (wood alcohol) in hand sanitizer sample manufactured at the same facility. Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date DMM VISSION has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and are packaged in 500ml and 1200ml plastic clear bottles with white tops. The lot numbers are LC2020407, LC2020408, LC2020502, LC2020504, LC2020507.  This product was first distributed nationwide to wholesale distributors on April 27, 2020 and finished on June 9th, 2020. The recalled products are as follows:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

October 6, 2020 12:00 PM

“A staff member at the IKEA Canada North York store, near Sheppard Avenue and Leslie Street, tested positive for COVID-19 on Oct.1. The employee last worked at the store on September 20.

Source: toronto.ctvnews.ca See Less
Reported By SafelyHQ.com User

October 21, 2020 12:00 PM

“Additional 4 employees confirmed positive for Covid-19 at Pacific Coast Fruit in Multnomah County. Investigation Start Date: 6/22/2020 , with the most recent onset of: 10/5/2020 New Cases of: 4

Source: www.oregon.gov See Less
Reported By SafelyHQ.com User