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Covid-19 OSHA Complaint, Nan McKay & Associates, 1815 Egbert Ave, SAN FRANCISCO, CA, 94124, USA

2 weeks ago

1815 Egbert Avenue, San Francisco, 94124 California, United States

Employees are not being notified by HR when they come in direct contact with employees that have tested positive for covid.

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-10-08

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The CDC announced that they are currently investigating a multistate outbreak of Salmonella Uganda infections linked to Pet Bearded Dragons. As of January 10, 2022, 44 people infected with the outbreak strain of Salmonella Uganda have been reported from 25 states (AL, AR, CA, CT,FL, KS, LA,... See More MA, MN, MO, MT, NE, NM, NV, NY, OR, PA, RI, SC, SD, TX, UT, VA, WA, WI). 15 people of the total have required hospitalization but no deaths have been reported to date.

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Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing... See More life-threatening inflammation of the heart, could result in infections that could be life-threatening.

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The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label attached.

Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers. Outer carton labeling (see images) Unit-Dose Cups (see image) Lohxa LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

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This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Lohxa LLC
Brand name: AVpak
Product recalled: Senna Syrup 5mL
Reason of the recall: Potential microbial contamination
FDA Recall date: January 12, 2022

Check the full recall details on fda.gov

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Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal... See More on the proximal end of the device handle detaching during use.

RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.

Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.

PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information below (1, 2, and 3).

The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.

Recalled Product Impacted (1)

- Destino Twist 14F (DST1405525). UDI Number: 885672011123. Lot Number: PQOC13475. Expiration Date 10-01-2021. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14073. Expiration Date 11-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14072. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14071. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13834. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13828. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13827. Expiration Date 08-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12995. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12632. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12633. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12345. Expiration Date 06-01-2024. Packaging State Type: Sterile.
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Destino 14F Twist Model (2)

Product: Destino Twist 14F
GTIN (Unit): 00885672011123
Model: DST1405525
Sheath & Dilator: S55CM D73CM
French Size: 14F
Quantity: 6 Units

Guidestar 14F - Model (3)

Product: Guidestar 14F
GTIN (Unit): 00885672010911
Model: D141103
Sheath & Dilator: S71CM D89CM
French Size: 14F
Quantity: 543 Units

Company name: Oscor Inc.
Brand name: Oscor
Recalled: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Reason of the recall: Hub cap and seal on the proximal end of the device handle may detach during use
FDA Recall date: January 12, 2022

Check the full recall details on fda.gov

Source: FDA
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Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received... See More that a unit may not dispense.

There is a risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication.

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 150892
- Expiration: Oct 2022

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 153199
- Expiration: Feb 2023

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 156041
- Expiration: Apr 2023

Company name: Padagis
Brand name: Perrigo
Product recalled: Nitroglycerin Lingual Spray
Reason of the recall: Unit may not properly dispense medication.
FDA Recall date: December 27, 2021

If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12 g bottle contained within a carton. The medication was distributed Nationwide in the USA to wholesalers and retailers.

Healthcare providers, distributors, and retailers that have product which is being recalled should stop distribution. Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product.

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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