[Posted 05/03/2016] AUDIENCE: Psychiatry, Internal Medicine, Patient ISSUE: FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or…
Brintellix (vortioxetine): Drug Safety Communication
<!– –> <!– Page Last Updated: 05/02/2016 –> Page Last Updated: 05/02/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall
[Posted 05/02/2016] AUDIENCE: Consumer ISSUE: Making It A Lifestyle, L.L.C. is voluntarily recalling all lots of 3rd Degree, Black Gold X Advanced and Black Label X capsule form supplements to the consumer level. The products have been found to contain undeclared sibutramine and sildenafil. These undeclared ingredients make these products an unapproved new drug for…
Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall
Posted [04/26/2016] AUDIENCE: Surgery, Dentistry, OBGYN, Nursing, Pharmacy ISSUE: Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to…
Fluconazole (Diflucan): Drug Safety Communication
<!– –> <!– Page Last Updated: 04/26/2016 –> Page Last Updated: 04/26/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall
<!– –> <!– Page Last Updated: 04/20/2016 –> Page Last Updated: 04/20/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Sterile Drug Products from Pharmakon Pharmaceuticals, Inc: CDER Statement
[Posted 04/16/2016] AUDIENCE: Pharmacy, Nursing, Health Professional ISSUE: FDA is alerting health care professionals not to use any drug products that are intended to be sterile and are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana, due to a lack of sterility assurance and other quality issues. BACKGROUND: FDA recently inspected Pharmakon’s…
Sterile Drug Products from Pharmakon Pharmaceuticals: Recall
UPDATED 04/20/2016. Pharmakon issues nationwide issued a voluntary nationwide recall of all sterile compounded products. All recalled products have a label that includes the Pharmakon Pharmaceuticals name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016. [Posted 04/16/2016] AUDIENCE: Pharmacy, Nursing, Health Professional ISSUE:…
March 2016
<!– –> <!– Page Last Updated: 04/15/2016 –> Page Last Updated: 04/15/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall
[Posted 04/14/2016] AUDIENCE: Pharmacy, Nursing, OB/GYN ISSUE: Hospira, Inc. is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL Single-dose vials, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02, to the hospital level due to a confirmed customer complaint for the presence of particulate matter, within one single-dose fliptop…