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Covid-19 OSHA Complaint, RG Food Corp., Calle Muñoz Rivera, Aguada, Rincón, Puerto Rico

January 13, 2021 12:00 PM

Calle Muñoz Rivera, Rincon, 00677 Rincón, Puerto Rico

1. Positive cases to covid 19 and have not disinfected the establishment. They haven't closed the place.

Alleged Hazards: 1, Employees Exposed: 10
Source: Osha.gov | Receip Date: 2020-12-03

Reported By SafelyHQ.com User

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“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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January 12, 2021 2:00 PM

“Company name: Midwestern Pet Foods Inc.
Brand name: Sportmix, Nunn Better, ProPac, and Others
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FDA Recall date: January 11, 2021
Recall details: Company Announcement Midwestern Pet Foods, Inc.,... See Moreof Evansville, IN is expanding its December 30, 2020 voluntary recall of certain dog and cat food products produced in our Chickasha Operations Facility to include all dog and cat pet food products made with corn products because those products may contain aflatoxin levels which exceed acceptable limits. Products were distributed nationally to online distributors and retail stores nationwide. Midwestern Pet Foods is expanding its voluntary recall out of an abundance of caution to help protect the health and safety of pets. The products recalled cover all that expire on or before July 9, 2022, depicted as “07/09/22” in the date code on the product, as discussed below. Products with expiration dates after 07/09/22 are not included in the recall. Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets. There have been reports of illnesses and deaths in dogs associated with certain lots of products. No human illnesses have been reported. Out of an abundance of caution, we have expanded this recall to cover all corn products containing pet foods with expiration dates prior to 07/09/22. If your pet shows signs of aflatoxin poisoning including sluggishness, loss of appetite, vomiting jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea, contact a veterinarian immediately. Provide a full diet history to your veterinarian. It may be helpful to take a picture of the pet food label, including the lot number and best buy date. Lot code information may be found on the back of bag and will appear in a three‐line code, with the top line in format “EXP 03/03/22/05/L#/B###/HH:MM”.

As explained above, this recall covers ONLY product manufactured at Midwestern Pet Food’s Chickasha, Oklahoma facility. Note that the unique Chickasha Facility identifier is located in the date code as a“05” and “REG. OK‐PFO‐0005” at the end of the date code.

In addition, the only Midwestern Pet Foods facility that produces product bearing a three‐line date code is our Chickasha Facility (See first image below).

Retailers and distributors should immediately pull recalled lots from their inventory and shelves. Do not sell or donate the recalled products. Retailers are encouraged to contact consumers who have purchased the recalled products, if you have the means to do so (frequent buyer cards, etc.). Pet parents: do not feed the recalled products to your pets or any other animals. Destroy the food in a way that children, pets and wildlife cannot access them. Wash and sanitize pet food bowls, cups, and storage containers. Always ensure you wash and sanitize hands after handling recalled food or any utensils which have contacted recalled food. Contact Midwestern Pet Foods Consumer Affairs at 800‐474‐4163, ext. 455 from 7AM to 4PM Central Time, Monday through Friday, or by email at info@midwesternpetfoods.com for additional information. This voluntary recall is being conducted in cooperation with the U.S. Food and Drug Administration. All other Midwestern Pet Foods products are unaffected by this recall action. Recalled products are as follows, with lot codes found in Expanded Recall Lot Numbers:

Pro Pac Adult Mini Chunk
Pro Pac Performance Puppy
Splash Fat Cat 32%
Nunn Better Maintenance
Sportstrail 50
Sportmix Original Cat 15
Sportmix Original Cat 31
Sportmix Maintenance 44
Sportmix Maintenance 50
Sportmix High Protein 50
Sportmix Energy Plus 44
Sportmix Energy Plus 50
Sportmix Stamina 44
Sportmix Stamina 50
Sportmix Bite Size 40
Sportmix Bite Size 44
Sportmix High Energy 44
Sportmix High Energy 50
Sportmix Premium Puppy 16.5
Sportmix Premium Puppy 33

Check the full recall details on fda.gov

Source: FDA
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