Safety Alerts & Recalls

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Latest Alerts

Serious Liver Disorder Associated with the Use of Didanosine (Marketed as Videx and Videx EC)
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using didanosine (also marketed as Videx and Videx EC). Non-cirrhotic portal hypertension occurs when blood flow in the major vein in the liver (the portal vein) slows down. This slowed blood flow can lead to the development of severely enlarged veins in the gastrointestinal system which sometimes leads to serious bleeding complications. The FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to the FDA's Adverse Event Reporting System (AERS). Based on these reports, the FDA has revised the didanosine, Videx, and Videx EC drug labels to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug. Didanosine is a medication used along with other drugs to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes AIDS. The brand name Videx was the first approved didanosine medication. Videx EC is a delayed-release version of Videx. For more information, please visit:
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Diflorasone Cream: Nycomed Recalls Two Lots
Nycomed US Inc. is recalling select lots of Diflorasone Diacetate Cream, 0.05% because routine testing found that the concentration of active ingredient was too high or too low in several samples from these lots. The following lot numbers are being recalled: Diflorasone Diacetate Cream, 0.05%, 15 grams per tube: Lot# 976D Diflorasone Diacetate Cream, 0.05%, 30 grams per tube: Lot# 329D Diflorasone is used to treat the itching, redness, dryness, crusting, scaling, inflammation (swelling), and discomfort of various skin conditions. This recall alert only applies to these two lots of the generic Diflorasone Diacetate Cream, 0.05% made by Nycomed. No other diflorasone products were involved in this recall. To view the FDA notice about this recall, please visit:
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Date Published Title Drug Source
2010-01-29 Serious Liver Disorder Associated with the Use of Didanosine (Marketed as Videx and Videx EC) Didanosine FDA
2010-05-12 Diflorasone Cream: Nycomed Recalls Two Lots Diflorasone FDA
2008-04-28 Nationwide class I recall Digoxin Manufacturer
2009-04-01 National Recall on Caraco Brand Digoxin Digoxin Manufacturer
2009-05-13 National Recall on A S Medication Solutions Digoxin Digoxin FDA
2009-09-14 Important Information About Digoxin (Lanoxin) Digoxin MediGuard CRT
2010-04-26 DIgoxin: West-ward Recalls Single Lot of Digoxin 125 mcg (0.125 mg) Tablets Digoxin FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Dilaudid Manufacturer
2008-12-24 Recall on a Single Lot of Hydromorphone HCl 2 mg Tablets Dilaudid FDA
2009-01-29 Recall on All ETHEX Brand Hydromorphone Tablets Dilaudid FDA
2009-04-01 FDA Warns Companies to Stop Producing Unapproved Narcotics Dilaudid FDA
2009-01-29 Recall on All ETHEX Brand Diltiazem Capsules Diltiazem Manufacturer
2014-01-17 Some Over-the-Counter Wart Removers Are Flammable Dimethyl Ether and Propane FDA
2014-11-26 FDA Warns About Case of Progressive Multifocal Leukoencephalopathy (PML) With MS Drug Tecfidera (Dimethyl Fumarate) Dimethyl Fumarate FDA
2008-12-15 Medication Error: Benadryl Itch Stopping Gel Mistaken for Benadryl Oral Liquid Diphenhydramine ISMP
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Diphenhydramine Manufacturer
2010-03-16 Recall of Several Brands of Diphenhydramine HCL 25 mg Capsules Diphenhydramine FDA
2010-05-12 Serious Side Effects from Swallowing Topical Benadryl Product Diphenhydramine FDA
2010-06-16 McNeil Expands Recall To Include Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels Diphenhydramine Manufacturer
2010-11-24 McNeil Issues Another Recall: Children's Benadryl Allergy Fastmelt Tablets Diphenhydramine Manufacturer
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