FDA MedWatch

Concentrated Acetaminophen Drops

Nationwide voluntary recall of all lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops in 16 ounce (473 ml) bulk containers, a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.

Libipower Plus

Product recalled because samples were found to contain undeclared Tadalalafil, an active ingredient of FDA approved drugs for Erectile Dysfunction. Tadalalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels.

Immunosuppressant Drugs: Required Labeling Changes

FDA requiring manufacturers of immunosuppressant drugs to update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy.

Medtronic Paradigm Quick-Set Infusion Sets

Nationwide recall because the affected infusion sets may not allow the insulin pump to vent air pressure properly, resulting in the device delivering too much or too little insulin, potentially leading to serious injury or death.

Mallinckrodt Sodium Chromate Cr-51 Injection

Recall of product due to subpotency and possibility of misdiagnosis or delayed diagnosis.

BiPAP Focus Non-Invasive Ventilator System, Respironics California

Class I Recall due to power supply failures that have occurred on some ventilators.

Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc

Nationwide recall because of the potential for contamination with Salmonella.

Arthroscopic Shavers: Ongoing Safety Review

Reports submitted to FDA describing instances of tissue remaining within certain arthroscopic shavers, even after the cleaning process was believed to have been completed.

Propoxyphene-containing Products

FDA taking actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses.

Lantus (insulin glargine)

FDA reviewing safety data regarding possible risk for cancer in patient with diabetes.

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