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Ukrop's Homestyle Foods Chicken Salad product - recalled due to misbranding and an undeclared allergen, USA

September 1, 2020 4:38 PM

United States

The FSIS announced the recall of approximately 1,202 pounds of ready-to-eat (RTE) chicken salad product by Ukrop’s Homestyle Foods due to misbranding and an undeclared allergen. The product may contain almonds, a known allergen, which are not declared on the product label.

The RTE chicken salad item was produced on August 26, 2020. The following product is subject to recall:

- 15-oz. round plastic containers containing “Ukrop’s Chicken Salad” with a sell by date of “09/02/20”.

The product subject to recall bears establishment number “P-19979” inside the USDA mark of inspection. These items were shipped to retail locations in North Carolina, Ohio, Virginia, and West Virginia. The problem was discovered after the firm received a consumer complaint reporting that the product contained almonds.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some product may be in retailer and consumers’ refrigerators. Retailers who have obtained these products are urged not to sell them. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. Consumers and members of the media with questions about the recall can contact Susan Rowe, Executive Administrator, Ukrop’s Homestyle Foods, at (804) 340-3050.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS

Reported By SafelyHQ.com User

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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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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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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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November 29, 2020 9:25 PM

“The FSA announced the recall of raw dog food products by Happy Hounds Wales Ltd because they may contain salmonella.

FSA advises consumers not to use the recalled product. Instead, return it to the store from where it was bought for a full refund. When handling and serving raw pet food it is alw... See Moreays advised to clean utensils and feeding bowls thoroughly after use.

- Frozen Beef Kidney (1kg). Batch code: 962. Best before: 10/26/2021
- Frozen Whole Heart (Individual Item). Batch code: 962. Best before: 10/26/2021
- Frozen Chicken and Beef Sleeve (1kg). Batch code: 1344/962. Best before: 11/2/2021
- Frozen Lamb and Beef Sleeve (1kg). Batch code: 962-966. Best before: 11/4/2021
- Frozen Diced Heart (1.5kg). Batch code: 962. Best before: 10/26/2021

Check the full recall details on food.gov.uk

Source: FSA
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December 1, 2020 8:00 PM

“Company name: WishGarden Herbs
Brand name: WishGarden Herbal Remedies
Product recalled: Happy Ducts Compress
Reason of the recall: Product may be contaminated with Cronobacter sakazakii.
FDA Recall date: December 01, 2020
Recall details: WishGarden Herbs, Inc. is voluntarily recalling one lot o... See Moref Happy Ducts Compress to the consumer level. After becoming aware of a possible supply chain contamination, a retained product was found to contain the Cronobacter sakazakii bacteria. WishGarden has initiated this recall due to the possible bacterial contamination of Happy Ducts Compress products of lot 53664.

WishGarden Herbs has reported that no medical illnesses or harmful effects have resulted from the recalled products thus far. To date 36 of 46 units in distribution have been accounted for. Happy Ducts Compress, when contaminated with Cronobacter sakazakii and applied to breast tissue of nursing women, may result in serious and sometimes life-threatening infections of nursing infants. Infants can be exposed while nursing through residual bacteria on their mother’s skin.

Additionally, topical application of Happy Ducts Compress contaminated with Cronobacter sakazakii may cause soft tissue infections in nursing women when applied to broken skin such as cracked nipples. Catherine Hunziker, WishGarden President, stated “As a leading herbal product company for more than 40 years, we take the safety of our products seriously and we feel it is important to recall this product out of an abundance of caution. Consumer safety is our highest priority.”

Happy Ducts Compress is used by nursing women as an external compress applied to breast tissue. It is packaged in 3 oz containers and labelled with UPC 6-56490-20223-5. The affected Happy Ducts Compress affected lot is 53664, Exp 08/2022. The lot and expiration date can be found above the label barcode. This product was distributed through select practitioners and online retailers.

WishGarden Herbs is notifying its distributors and customers by phone and email. Consumers who have purchased this product through their practitioner or retail site should not open the package or should discontinue use immediately. Instead, they should dispose of the product or mail it directly to WishGarden Herbs corporate headquarters at 321 South Taylor Ave. Suite 100 Louisville, CO 80027 for a full refund.

Consumers with questions regarding this recall can contact WishGarden Herbs by calling the company’s recall hotline at 720-889-9878 (M-F, 9am - 5pm MST) or Email: recall@wishgardenherbs.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this 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. 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

December 9, 2020 5:00 PM

“Company name: Torrent Pharmaceuticals Limited
Brand name: Torrent Pharmaceuticals Limited
Product recalled: Anagrelide Capsule USP 1mg
Reason of the recall: Due to dissolution test failure
FDA Recall date: December 09, 2020
Recall details: Torrent Pharmaceuticals Limited is voluntarily recall... See Moreing one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide could increase the risk of clotting (blood coagulation) and clotting or bleeding events such as a heart attack or stroke which could be life-threatening.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelet cells. As the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment, patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.  The product subjected to the recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing the product.

- Anagrelide Capsule USP 1mg,100-count bottles. NDC: 13668-462-01. Lot/Batch: BFD1G001. Expiration Date: 12/2021

Anagrelide Capsules, USP were distributed nationwide to Torrent’s wholesale distributor and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time (Monday-Friday), voicemail available 8:00 am – 5:00 pm Eastern Time (Monday-Friday).

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product should be directed to Qualanex at 1-888-424-4340 (live calls received 8 am - 5:00 pm Eastern Time, Monday-Friday).

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 on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

December 28, 2020 8:00 PM

“Company name: Sunstar Americas, Inc.
Brand name: Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz
Reason of the recall: Potential contamination with Burkholderia lata
FDA Recall date: December 28, 2020
Recall details: Schaumburg, Illinois, Sunstar Americas, I... See Morenc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020. 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, 29 adverse events have been reported to SAI related to this recall. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.

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

- 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
- 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images below Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies. SAI is notifying its direct distributors and customers by USPS Priority mail 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 SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. 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:

-Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 16 fl.oz. Amber Bottles. NDC #: 052376-021-02. Product Code: 1789P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

- Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 4 fl.oz. Amber Bottles NDC #: 052376-021-04. Product Code: 1788P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022.

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. Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue. 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

January 7, 2021 9:21 PM

“Ate food there and my whole family is sick See Less
Reported By SafelyHQ.com User

January 8, 2021 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL
Reason of the recall: Presence of particulate matter
FDA Recall date: January 08, 2021
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Ketoro... See Morelac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine Injection should not exceed 5 days. Listed below is a table of the recalled lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.

Product Name/Product size: Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial
NDC Number: 63323-162-01
Product Code: 160201
Batch Number: 6121083
Expiration Date: 02/2021
First Ship Date: 03/28/2019
Last Ship Date: 09/03/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors 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 the affected lot, and to return the product to Fresenius Kabi.

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

January 17, 2021 11:59 PM

“The FSA announced the recall of several dog food products by Mars Petcare UK because they may contain high levels of vitamin D which exceed the maximum permitted intake.

FSA advises pet owners that if they have bought any of the following dog food products, you should stop feeding them to your do... See Moreg and contact Mars Petcare Customer Service at 0800 013 3131. If you have concerns that your pet may be showing symptoms of illness after eating one of the affected products, please contact a veterinarian.

- CHAPPIE Complete Chicken & Wholegrain Dry Dog Food (3kg). Batch code: 045F9MIN05. Best before: 44692
- PEDIGREE Mixer Adult Dry Dog Original (3kg). Batch code: 046E9MIN05 | 046F9MIN05 | 048A9MIN05. Best before: 12 February 2022 | 20 February 2022 | 22 February 2022
- PEDIGREE Mixer Adult Dry Dog Food Original (10kg). Batch code: 046E9MIN08 | 047C9MIN08. Best before: 12 February 2022 | 17 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (12kg). Batch code: 046C9MIN08 | 046D9MIN08 | 046E9MIN08. Best before: 10 February 2022 | 11 February 2022 | 12 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (2.6kg). Batch code: 045F9MIN05 | 047A9MIN05. Best before: 06 February 2022 | 15 February 2022

High levels of vitamin D fed to a pet over a short period (weeks/months) should not cause undue concern. Over a longer period of feeding, ingestion of elevated levels can lead to potential dog health issues. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction.

Check the full recall details on the FSA website food.gov.uk

Source: FSA
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Reported By SafelyHQ.com User