Caffeinated alcoholic beverages to me are something of an oxymoron. Like “jumbo shrimp”. “Seriously joking”. “Taped live”. And “working vacation”.

After today, though, I feel confident in predicting a sudden rush of caffeinated alcoholic beverage purchases. That’s because the FDA today “notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.”

In other words, you’re in range now. Smile when you see the flash.

The logic for the FDA’s targeting of caffeinated alcoholic beverages is explained in the press release…

“Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS).  FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.  For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.”

Soooo…. flavored alcoholic beverages might also be targeted under this interpretation, right? Or anything not specifically OKed by the FDA?

The press release also spells out that the FDA isn’t going to be messing around with the preliminaries this time out.

“The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned.  FDA’s letter informed each company that if FDA determines that the use of caffeine in the firm’s alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.”

And who got a copy of the FDA’s nastygram?

Buy ’em now if you want ’em.

Here’s the link to the FDA notification here.

Little shards of stainless steel aren’t too good for your bloodstream the last time I checked.

This voluntary recall from Hospira is for “85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80… The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall.”

The reason for this recall is that… “some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process.”

In the list of things this particulate matter might do to you is “…potentially act as emboli and impede blood flow.  Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS).  Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.”

You know. The usual side effects.

Fortunately nobody has been hurt by this, and Hospira is asking that “anyone with an existing inventory should quarantine the product immediately and call Stericycle at 1-866-654-0725 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.”

Here’s the link to the official FDA recall.

When you make a product that’s designed to clamp down on the aorta and drip solution to stop the heart during cardiopulmonary bypass procedures, you really should have that product go through some ruthlessly insane levels of quality control. Then test the product again, retest it, and then test it some more.

Well, today’s FDA recall is for a product that does just that. The official CLASS 1 recall is for “Edwards Lifesciences CardioVations EndoClamp Aortic Catheter ” and is specifically targeting “CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65”.

The problem? According to the recall notice, “The balloon catheters may spontaneously rupture during surgery.”

Oh yeah. That’s FUBAR. Big time.

The recall was started by the company on September 24th, but the FDA just issued the public notice today.

The CLASS 1 bit on FDA releases is “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

If you have CardioVations EndoClamp Aortic Catheter Model Numbers EC1001 and/or EC65, you can “contact the company’s Customer Service Organization at 1-800-424-3278, Monday through Friday, 6:00 a.m. – 4:30 p.m., Pacific Time.”

Here’s the link to the official FDA recall.