Drug Safety Alerts and Recalls

Tygacil labeling updated to include increased mortality risk

September 01, 2010

The FDA is reminding healthcare professionals that intravenous Tygacil (tigecycline, from Pfizer) can increase mortality risk in the treatment of serious bacterial infections.
 

FDA warns consumers to avoid TimeOut Capsules

August 26, 2010

The FDA has warned consumers not to take TimeOut Capsules, which are marketed as a dietary supplement for sexual enhancement.
 

FDA recalls Mr. Magic Male Enhancer from Don Wands

August 24, 2010

Glow Industries and the FDA have notified consumers of a voluntary nationwide recall of Mr. Magic Male Enhancer from Don Wands.
 

FDA reviews cardiovascular risks associated with Stalevo

August 23, 2010

The FDA has notified healthcare professionals that clinical trial data suggesting that Stalevo (carbidopa, levodopa, entacapone, from Novartis) increases the risk for cardiovascular events compared to carbidopa/levodopa (Sinemet, from Bristol-Myers Squibb) is being evaluated.
 

FDA proposes withdrawal of midodrine HCl

August 16, 2010

The FDA has issued a Proposal to Withdraw Marketing Approval for ProAmatine (midodrine HCl, from Shire), used in the treatment of orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.
 

FDA recalls Prolatis' male sexual enhancement product

August 13, 2010

Prolatis' and the FDA announced a nationwide voluntary recall of its product Prolatis' after lab analysis found the product to contain undeclared sulfoaildenafil.
 

FDA warns of aseptic meningitis risk with Lamictal

August 13, 2010

The FDA has informed healthcare professionals and patients that Lamictal (lamotrigine, from GlaxoSmithKline) can cause aseptic meningitis.
 

Novacare recalls male enhancement dietary supplements

August 11, 2010

Novacare LLC and the FDA have announced a nationwide voluntary recall of products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).
 

Revivexxx Extra Strength dietary supplement recalled

August 09, 2010

EZVille and the FDA announced a recall of all lots of Revivexxx Extra Strength, marketed as a dietary supplement sexual enhancer for men, after FDA lab analyses found the product to contain undeclared tadalafil.
 

Solo Slim weight loss supplement recalled

August 09, 2010

EZVille and the FDA announced a recall of all lots of Solo Slim and Solo Slim Extra Strength capsules after FDA lab analyses showed the products to contain undeclared didesmethyl sibutramine.
 

Download the MPR Mobile & Desktop Edition for free access to over 4,000 up-to-date, concise drug monographs on your computer or mobile device.

New Drug Products

TRIBENZOR 20/5/12.5mg

8/26/2010

Active Ingredient(s): Olmesartan medoxomil 20mg, amlodipine (as besylate) 5mg, hydrochlorothiazide (HCTZ) 12.5mg; tabs.
 

OLEPTRO

8/19/2010

Active Ingredient(s): Trazodone HCl 150mg, 300mg; scored ext-rel tabs.
 

VIMOVO

8/12/2010

Active Ingredient(s): Naproxen 375mg + esomeprazole (as magnesium trihydrate) 20mg; naproxen 500mg + esomeprazole (as magnesium trihydrate) 20mg; delayed-release tablets.
 

DULERA 100/5

8/5/2010

Active Ingredient(s): Mometasone furoate 100mcg, formoterol fumarate dihydrate 5mcg; per inh; metered-dose inhaler; contains HFA.
 

PREVNAR 13

7/29/2010

Active Ingredient(s): Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) 30.8micrograms of saccharides per 0.5mL; susp for IM inj; contains aluminum.
 

Job Search


 Subscribe to the RSS for this page  [view all our RSS feeds here]

This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization.

Your use of this website constitutes acceptance of Haymarket Media's Privacy Policy and Terms & Conditions