Promethazine Hydrochloride Injection
Today, September 16, 2009
Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine.

LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)
Today, September 16, 2009
Class I recall due to failure or delay in delivery of therapy.

Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm)
Friday, September 11, 2009
Nationwide recall due to risk of obstruction and inability to ventilate patient.

Covidien Pedi-Cap End-Tidal CO2 Detector
Thursday, September 10, 2009
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.

ConMed Linvatec – Universal Cables and Power Pro Handpieces
Thursday, September 10, 2009
Class 1 recall due to risk of powered device self-activation and injury to patient or surgical staff.

Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand)
Thursday, September 10, 2009
Two lots (35,760 cartons) stolen in Texas. Pharmacies encouraged to verify pedigree documentation for all purchases of Dey-labeled Albuterol.

Penumbra Neuron 5F Select Catheter
Wednesday, September 09, 2009
Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture.

Philips Avalon Fetal Monitors
Friday, September 04, 2009
Safety alert issued due to complaints of inaccurate output readings that may lead to failure to identify fetal distress.

Myfortic (mycophenolic acid)
Thursday, September 03, 2009
Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic.

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009
Monday, August 31, 2009
UPDATE 08/31/2009 – Supplemental Q&As added to 08/04/2009 safety information (increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers).

Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
Friday, August 28, 2009
FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Precautions added to prescribing information.

Intelence (etravirine)
Thursday, August 27, 2009
Reports of severe, potentially life-threatening and fatal skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hypersensitivity reactions.

Levemir Insulin (Novo Nordisk)
Wednesday, August 26, 2009
[UPDATED 08/26/2009] Stolen vials of Levemir still may be on the market. FDA received multiple reports of patients who suffered adverse events due to poor control of glucose levels after using vial from stolen lots.

Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dr?¤eger/Hill-Rom]
Tuesday, August 25, 2009
Voluntary recall classified as Class 1 due to the reasonable probability that use of these products will cause serious injury or death.

Steam Dietary Supplement
Monday, August 24, 2009
[UPDATED] Nationwide recall expanded, new lot added due to undeclared drug ingredient.

Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
Monday, August 24
FDA is reviewing reports of serious liver injury, including liver failure.

Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]
Monday, August 24, 2009
Nationwide recall due to potential for needle to detach from syringe, become stuck in the vial, push back into syringe, or remain in skin after injection.

Ibuprofen (Unapproved) topical drug products
Friday, August 21, 2009
The agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

Hospira, Inc. Device Recall
Monday, August 17, 2009
Potential risks from Hospira, Inc. power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires.

Dextroamphetamine, Amphetamine 20mg Tablets
Friday, August 14, 2009
Recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.