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Nostrum Laboratories Metformin HCl Extended Release Tablets, USP 500 mg - recalled due to NDMA exceeds acceptable daily intake limit, USA

November 3, 2020 10:00 AM

United States

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 recalling 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

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

Related Reports

December 2, 2020 1:00 PM

“Company name: MPM Medical, LLC
Brand name: MPM Medical
Product recalled: Regenecare HA Topical Anesthetic Hydrogel
Reason of the recall: Burkholderia cepecia contamination.
FDA Recall date: December 02, 2020
Recall details: MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel... See Moreto the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.

Risk Statement: Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which includes symptoms such as fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion and possibly death.

To date, MPM Medical has not received any reports of adverse events related to this recall. Regenecare HA Hydrogel is an OTC product that contains 2% lidocaine and is used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations and is packaged in 3 oz. plastic tubes and distributed in boxes of 12. The product can be identified by NDC # 66977-107-03, and the lot number 41262 with date 2021-01 debossed on the tube crimp as shown in the images.

Regenecare HA Hydrogel Lot 41262 was distributed nationwide to wholesalers and healthcare facilities. MPM Medical is notifying its distributors and customers by first class mail, electronic mail, and phone call and is arranging for return of all recalled product. Patients and healthcare facilities in possession of this product which is being recalled should stop using and dispensing. Consumers with questions regarding this recall can contact MPM Medical by phone at 1-800-232-5512 (toll-free) Monday through Friday between 7AM and 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.

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.

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
MPM Medical 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

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
See Less
Reported By SafelyHQ.com User

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
See Less
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
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
See Less
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
See Less
Reported By SafelyHQ.com User

October 28, 2020 11:00 AM

“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: October 28, 2020
Recall details: Sunstar Americas, Inc. (SAI) is voluntarily... See Morerecalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This 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 SAI related to this recall. 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 by 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 are detailed in the link below.

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
See Less
Reported By SafelyHQ.com User

COVID-19 OSHA Complaint, Gilbert Center For Family Medicine, East Warner Road, Gilbert, AZ, USA

Gilbert Center For Family Medicine, East Warner Road, Gilbert, AZ, USA

December 4, 2020 2:46 PM

“Patients in waiting room without mask. Receptionists seem not to care. Did not ask patient to wear a mask or offer one. Most Dr. offices should have masks available so not sure why the patient was allowed to be maskless in the waiting room. See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

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
See Less
Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

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

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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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Reported By SafelyHQ.com User

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

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

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

December 2, 2020 1:00 PM

“Company name: MPM Medical, LLC
Brand name: MPM Medical
Product recalled: Regenecare HA Topical Anesthetic Hydrogel
Reason of the recall: Burkholderia cepecia contamination.
FDA Recall date: December 02, 2020
Recall details: MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel... See Moreto the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.

Risk Statement: Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which includes symptoms such as fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion and possibly death.

To date, MPM Medical has not received any reports of adverse events related to this recall. Regenecare HA Hydrogel is an OTC product that contains 2% lidocaine and is used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations and is packaged in 3 oz. plastic tubes and distributed in boxes of 12. The product can be identified by NDC # 66977-107-03, and the lot number 41262 with date 2021-01 debossed on the tube crimp as shown in the images.

Regenecare HA Hydrogel Lot 41262 was distributed nationwide to wholesalers and healthcare facilities. MPM Medical is notifying its distributors and customers by first class mail, electronic mail, and phone call and is arranging for return of all recalled product. Patients and healthcare facilities in possession of this product which is being recalled should stop using and dispensing. Consumers with questions regarding this recall can contact MPM Medical by phone at 1-800-232-5512 (toll-free) Monday through Friday between 7AM and 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.

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.

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
MPM Medical 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

Covid-19 OSHA Complaint, 10th Street Pub, 10050 E 10th Street, INDIANAPOLIS, IN, 46229, USA

10th Street Pub, 10050 E 10th Street, INDIANAPOLIS, IN, 46229, USA

December 3, 2020 12:00 PM

“No mask wearing or hand washing by employees and noncompliance to Governor's orders-- people sitting at bar, no adherence to table distance measurements or capacity restrictions.


Source: Osha.gov | Receipt Date: 2020-10-13 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Brite Light Welding & Fab, 184th Street East, Puyallup, WA, USA

Brite Light Welding & Fab, 184th Street East, Puyallup, WA, USA

November 10, 2020 12:00 PM

“Alleged Hazards: - Employer did not disinfect after employee tested positive for COVID-19 - Employer is not enforcing employee wear masks as required by the Governors guidelines


Source: Osha.gov | Receipt Date: 2020-09-28 See Less
Reported By SafelyHQ.com User