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postheadericon FDA Issues Label Changes for 47 Drugs

Saturday, 17 September 2011 11:58 | Written by Drug Recall Lawyer | PDF | Print | E-mail

Forty-seven marketed products have recently undergone a label change based on new findings concerning their risks. The U.S. Food and Drug Administration (FDA) has mandated the alteration of safety warnings, which means the packaging of these products have updated their boxed warnings, their contraindications, and precautions as well as their adverse reactions. The FDA may decide to recall some of these drugs after an assessment of their harmfulness.

The following is a list of the drugs included in this label change:

Aciphex (rabeprazole sodium) Delayed-Release Tablets

Afinitor (everolimus) Tablets

Aldactazide (spironolactone/hydrochlorothiazide) Tablets

Avandia (rosiglitazone maleate)

Avandamet (rosiglitazone maleate/metformin hydrochloride)

Avandaryl (rosiglitazone maleate/glimepiride) Tablets

Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets

Biaxin Filmtab (clarithromycin tablets, USP) Biaxin XL Filmtab (clarithromycin extended-release tablets),Biaxin Granules (clarithromycin for oral suspension, USP)

Dexilant (dexlansoprazole) Delayed Release Capsules

Genotropin (somatropin [rDNA origin] for Injection

Humalog (insulin lispro [rDNA origin]) Injection

Imuran (azathioprine) Tablets and Injection

Levatol (penbutolol sulfate) Tablets

Micardis HCT (telmisartan/hydrochlorothiazide) Tablets

Norditropin Cartridges (somatropin [rDNA origin] injection)

Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide Tablets

Prevacid(Lansoprazole) Delayed-Release Capsules

Prevacid SoluTab (Lansoprazole) Delayed-Release Orally Disintegrating Tablets

Prilosec (omeprazole) Delayed Release Capsules and Prilosec (omeprazole magnesium) For Delayed Release Oral Suspension

Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension 40 mg

Protonix (pantoprazole sodium) Delayed-Release Tablets, Protonix I.V. (pantoprazole sodium) for Injection

Purinethol (mercaptopurine) Tablets

Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate) Extended-ReleaseTablets

Sutent (sunitinib malate) Capsules

Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets

Uniretic (moexipril hydrochloride/hydrochlorothiazide)

Vimovo (naproxen/esomeprazole magnesium) Tablets

Zegerid (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension

Ziac (bisoprolol fumarate/hydrochlorothiazide) Tablets

 
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