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Drug and Device Safety

Keep up to date with recent drug alerts and through the FDA drug alert system and Vaccine Adverse Event Reporting System (VAERS).

Recent Drug Alerts

Learn more about recent FDA drug safety alerts and communications that may impact your patients.

Alteplase

Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials that were co-packaged with sterile water for injection. The vials of sterile water may be cracked or chipped at the neck of the vial and leaking. Lot #s being recalled are 3128243, 3141239, and 3166728.  Read the full FDA Alert.

Lorazepam Oral Concentrate

Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings, or has dose markings that are shifted. Read the full FDA Alert.

 

FDA Drug Safety Labeling changes

On September 1, 2016 the FDA launched a database to provide the public with information on drug safety labeling changes. Search the Drug Safety Labeling Changes database

Free FDA Email Alert Notifications

MedWatch is the FDA Safety Information and Adverse Event Reporting Program. You can subscribe to MedWatch Safety Alerts for email alerts or follow MedWatch on Twitter.

Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national passive surveillance system that monitors the safety of all vaccines licensed for use in the United States. VAERS reports are available through CDC WONDER. All personal identifying information is removed prior to posting the public data.


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