Cross Contamination

Updated:

Fresenius Kabi USA Dexmedetomidine HCL in 0.9% Sodium Chloride Injection - recalled due to cross contamination with Lidocaine, USA

3 years ago •source www.fda.gov

Recall notice

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 single lot of Dexmedetomidine HCl … See More
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 www.fda.gov

Source: FDA
See Less

#drugs #recall #crosscontamination #us

Fresenius Kabi USA Dexmedetomidine HCL in 0.9% Sodium Chloride Injection - recalled due to cross contamination with Lidocaine photo #1
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Recent Interesting Reports

B

Package whitout being ask, Am Eifeltor 501, 50997 Köln, Rodenkirchen, Germany

3 weeks ago •reported by user-brqd6771

I also receive today a package whitout being ask whith Black wireless headphone and White earplug headphone. What can I do? I dont need this!

Return DI RETURN ONLY, NOT FOR SALES Postlink Am Eifeltor 501, 50997 Köln, Germany

#unorderedpackage #delivery #ameifeltor #koln #nordrheinwestfalen #de

Package whitout being ask photo #1
55

Nutrena Country Feeds Meat bird 22% Crumble (RV) - recalled due to non-inclusion of vitamin D, Bryson City, North Carolina, USA

6 days ago •source www.fda.gov

Recall notice

Cargill’s animal nutrition business is conducting a voluntary recall of Nutrena® Country Feeds® Meat bird 22% Crumble (RV) due to non-inclusion of Vitamin D. The affected products were manufactured and sold in the eastern United States and are being recalled from retail outlets in the Alabama, Georgia, … See More
Florida, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia markets. Cargill discovered the issue after receiving a report of young meat birds diagnosed with rickets.

Lack of Vitamin D in meat bird diets can lead to mineral deficiencies and bone issues, including rickets in growing birds. Symptoms include lameness and rubbery bones.

The recalled product is:
- Product: Nutrena® Country Feeds® Meatbird 22% Crumble (RV), Size: 50 lb. bag, Lot Code: All lots, Product Code: 95188, Species: Meat birds (Broilers, Turkeys, Ducks, Geese and Pheasants, Manufacture dates: July 2022-March 2024, Shelf Life (Days): 120.
The lot code and manufacture date can be found on the bottom right-hand side of the label.

Consumers and other end users who have any of the affected lots in their possession should return remaining product to their local dealer or retailer for a replacement or full refund.

In case your birds experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Cargill
Brand name: Nutrena Country Feeds
Product recalled: Meat bird 22% Crumble (RV)
Reason of the recall: Non-inclusion of Vitamin D
FDA Recall date: April 13, 2024

Source: www.fda.gov
See Less

#recall #cargill #petfood #brysoncity #northcarolina #us

Nutrena Country Feeds Meat bird 22% Crumble (RV) - recalled due to non-inclusion of vitamin D photo #1
4

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