Safety Alerts and Recalls

Safety Alerts & Recalls

"Keepsake" Fetal Imaging May Do More Harm Than Good, FDA Warns

The Food and Drug Administration (FDA) is warning consumers that fetal ultrasound imaging and Doppler fetal ultrasound heartbeat monitors are prescription devices designed to be used by trained healthcare professionals and are not intended for over-the-counter (OTC) sale or use for creating fetal keepsake images and videos.

Baxter Recalls Two Lots of Sodium Chloride Injection

Baxter announced a voluntary recall of two lots of 0.9% Sodium Chloride Injection due to particulate matter found in the solution. The particulate matter was identified as a fragment of the frangible from the vial adapter.

Antipsychotic Linked to Rare, Potentially Fatal Skin Reaction

The Food and Drug Administration (FDA) is warning that ziprasidone, an atypical antipsychotic agent, has been linked to a rare but serious skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can progress to other parts of the body.

False PT/INR Results May Appear for Some Patients

Alere has issued a voluntary correction to users of the Alere INRatio and INRatio 2 PT/INR Monitor system of certain medical conditions that should not be tested with the system.

Weight Loss Caps Contain Withdrawn Drug

The Food and Drug Administration (FDA) is warning consumers to not buy or use Slim-Vie, a supplement marketed for weight loss.

Rare Brain Infection May Be Linked to MS Drug

The FDA has issued a warning about one patient with multiple sclerosis (MS) being treated with Tecfidera (dimethyl fumarate; Biogen Idec) who developed progressive multifocal leukoencephalopathy (PML) and later died.

Laparoscopic Power Morcellators Get Safety Labeling Update

The Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in hysterectomy or myomectomy procedures for the majority of women.

Empty Gabapentin Capsules Prompt Recall

Aurobindo Pharma announced a voluntary recall of one lot Gabapentin Capsules 300mg at the consumer level due to the discovery of some empty capsules.

Mislabeling Leads to Recall of Highly Concentrated Potassium Chloride

Baxter announced a voluntary recall of one lot of Highly Concentrated Potassium Chloride Injection 10mEq/100mL at the user level due to a complaint of mislabeling of the overpouch.

Hidden NSAIDs Found in Herbal Supplement

The Food and Drug Administration (FDA) is warning consumers not to buy or use "Feng Shi Ling," a product marketed as an herbal drug for pain due to rheumatoid arthritis and osteoporosis.