Recall of all sterile drug products by Med Prep Consulting in NJ

FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey


The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, N.J, a specialty pharmacy licensed by the state of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.

The magnesium sulfate products may have been distributed to additional facilities in Connecticut, New Jersey, Pennsylvania, and Delaware. Until further notice, health care providers should stop using all products made by Med Prep Consulting Inc. and return them to the company.

“Giving a patient a contaminated injectable drug could result in a life-threatening infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We do not have reports of patient infections. However, due to a lack of sterility assurance at the facility and out of an abundance of caution, this recall is necessary to protect patients.”

This investigation is ongoing. The FDA is working with the Centers for Disease Control and Prevention and state officials in New Jersey and Connecticut to determine the scope of the contamination. The level of recall is to the user level, this includes regional hospital pharmacies and related departments, and physician’s office practices. This recall includes all products distributed through March 15, 2013.

In addition to the recall, on March 15, 2013, the New Jersey State Board of Pharmacy entered into an Interim Voluntary Consent Order with Med Prep Consulting Inc. Under the Order, the firm has temporarily halted all production operations, including the processing and shipping of medications.

Med Prep Consulting Inc. prepares a number of sterile products for intravenous administration for a number of medical conditions. The firm’s products include antibiotics, general and local anesthetics, cardiac, labor and delivery and pain management medications.

To date, the FDA is not aware of any reports of injury or illness associated with the recalled magnesium sulfate intravenous solution. The FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:

Complete and submit the report online at www.fda.gov/medwatch/report.htm

Last segment of the Bruiser Chronicle...

...that is until the next time he visits.

Good morning, Bruiser. He finally understands he shouldn't wake me up so early and then we have Fred throwing us out of bed. Yikes, I forgot I have to go to South Jersey to attend Uncle Sonny's funeral. Uncle Sonny (aka as the family's Santa Claus) is now in heaven with Aunt Theresa (she passed in October).



I am not rising until I
have my belly rubbed. 
After all, there are some perks
to being a house guest.



No problem, I will take a nap while you are gone.



It is about time you get home.
I am ready to play!



I will promise anything if you
don't drag me out in the snow!



Buiser and I are doing a happy dance! We get to spend one more night together. Grandpa is coming in the morning to pick him up to take him home to his Mommy and Daddy. I know they can't wait to snuggle with their little love bug.

Mom, Claudia was typing away
so I had to get her attention.
Oh boy, did I get her to notice me.
She was a good sport, she got on the
floor and played too.

One less stuffy for May's garage sale.
Laura, I am sure you are laughing at us
(sorry about your...I think it was a dog)!

All kidding aside, thanks Renee & Rich for letting me share a week with Bruiser. He gave me lots of material to blog about. He is a delight and he is always welcome to stay with us. He will be missed around here. 

Sunday with His Cuteness

We just came back from a walk and a sprint in the dog run. Sorry to say there were no dogs to play with Bruiser. He impressed Fred by leading the way to the doggie play area. He is not only cute and loveable, he is very smart too. Once there he showed us how fast he can run. He is a speed demon with very little stamina!

I am sure you are wandering if Bruiser respected my wishes about rising before the sun. Yes, he did! He didn't annouce the wake-up call until 7:55. It may not have had anything to do with our conversation yesterday. More than likely, it has something to do with him staying up late wih me last night. I am not going to to divulge his bedtime, after all, it was Saturday night.

No, no, not another walk.
Where is Fred when you need him?
Hey Fred isnt it nap time?

Bruiser has become a pro at the steps now. He still won't cross the bridge over the pond in the the development; no big deal, we just walk around the pond.

I sewed the stuffed cat that Bruiser beheaded. I decided not to attach the head this way there are two toys that he can carry around. Yesterday he must have grabbed a pair of my socks out of the clothes basket because I was surpried when I saw him walking around with them. So now he has another object to carry. I wonder if he thinks he is a retriever.

Why did she have to go and sew this?
Now I will just have to show her once again
what I think of cats!

1 cat body, 1 cat head, 1pair of socks--
all will be waiting for Bruiser the next time he visits us.

R & R, don't you have somewhere to go in April?

Happy ST Patrick's Day

to our friends

and Bruiser's family!

Saturday with Bruiser

It is the third day of Bruiser’s stay with us. We started off with an hour’s walk this morning and met up with Coco and both pups became fast friends. Afterward, Bruiser had some fun in the dog run. I figured I would treat him to some off-leash time before I had a serious talk with him.

Dog run all to Bruiser

He decided it was time to go

When we arrived home we enjoyed our breakfast together. We both had our usual. Bruiser didn’t want any coffee. After breakfast I told him I had to have a conversation with him. So he patiently sat and listened to me. “Bruiser, you are the very best dog (Jackson & Louie, you are still top dogs)…but you must understand this woman does not like getting out of bed before the sun is up, especially on the weekend. So maybe tomorrow you can wait until the sun is completely in the sky before you are ready for your first walk of the day."

He is listening but I don't know
what is going on in his head.

I  will try but I can't promise.
A dog has to go when a dog has to go.

Good place for a nap on a snowy day.
Comfy in here with the fireplace warming up the house.
I think I will just catch a few winks
before Claudia looks to take me out again.

Let me sit up here with Claudia, she may need
some inspiration playing Words. Oh, wait, how
can I bark out the letters if I have a stuffy in my mouth?
Oh well, I am not dropping the stuffy,
she will just have to come up with her own words.

  

Taking advantage of Fred watching a movie.

He is a talented guy--he can do two things at once.

A little scratch to the right, please.

Oh, I am totally shameless.

NEWS ALERT:
Bruiser finally went up the steps by himself!
GO BRUISER