FDA MedWatch

Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine.

Class I recall due to failure or delay in delivery of therapy.

Nationwide recall due to risk of obstruction and inability to ventilate patient.

Class I recall because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe.

Class 1 recall due to risk of powered device self-activation and injury to patient or surgical staff.

Two lots (35,760 cartons) stolen in Texas. Pharmacies encouraged to verify pedigree documentation for all purchases of Dey-labeled Albuterol.

Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture.

Safety alert issued due to complaints of inaccurate output readings that may lead to failure to identify fetal distress.

Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic.

Reports of severe, potentially life-threatening and fatal skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hypersensitivity reactions.