[Posted 02/02/2017] AUDIENCE: Nursing, Surgery, Dentistry, Patient ISSUE: FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years….
Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall – Product Contains Banned Ephedra Alkaloids
[Posted 02/09/2017] AUDIENCE: Consumer, Emergency Medicine ISSUE: Kingsway Trading Inc. is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary…
Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall – Particulate Matter
[Posted 02/09/2017] AUDIENCE: Pediatrics, Cardiology, Critical Care Medicine ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to…
Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall – Alarm Error
[Posted 02/09/2017] AUDIENCE: Risk Manager, Nursing ISSUE: CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may…
HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall – Lack of Sterility Assurance
[Posted 02/15/2017] AUDIENCE: Consumer ISSUE: Synergy Rx Pharmacy recalled all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a lack of sterility assurance. This recall impacts all sterile products distributed between 06/01/2016 and 12/22/2016. The product was only distributed to physician…
Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall – High Fracture Rate
[Posted 02/16/2017] AUDIENCE: Risk Manager, Orthopedics ISSUE: Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function,…
XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall – Undeclared Drug Ingredient
[Posted 02/22/2017] AUDIENCE: Consumer ISSUE: Organic Herbal Supply, Inc. is conducting a voluntary nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules. FDA analysis has found the product to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredients…
Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall – Products May Contain Synthetic or Natural Latex
[Posted 02/24/2017] AUDIENCE: Pharmacy, Risk Manager ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston, is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals…
Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall – Potential Lack of Sterility Assurance
[Posted 02/27/2017] AUDIENCE: Urology, Pharmacy, Patient ISSUE: Endo Pharmaceuticals Inc. is recalling one lot of Edex (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo of a defect in the crimp caps used in the manufacture of the subject product…
Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall – Undeclared Drug Ingredient
[Posted 03/07/2017] AUDIENCE: Consumer ISSUE: A&H Focal Inc. is voluntarily recalling all lots marketed as dietary supplements for male sexual enhancement from January 2014 to present. These products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e.sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient…