Safety Alerts and Recalls

Safety Alerts & Recalls

FDA Finds Undeclared Salicylic Acid in Weight Loss Caps

Novacare announced a voluntary recall of dietary supplements marketed as an aid to weight loss due to undeclared salicylic acid.

Particulate Matter Leads to Recall of Some Allergan Ophthalmic Products

Allergan plc. announced a voluntary recall of specific lots of REFRESH Lacri-Lube, REFRESH PM, FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment USP) 10%/0.2% due to the presence of particular matter.

FDA: Reports of Severe Allergic Reactions with Picato

The Food and Drug Administration (FDA) is warning about reports of severe allergic reactions and herpes zoster associated with the use of Picato (ingenol mebutate topical gel).

Cracked Child-Resistant Bottle Caps Prompt Oncology Drug Recall

Merck announced a voluntary recall of Temodar (temozolomide) and its generic Temozolomide (Sandoz) capsules due to the potential for the bottle caps to be cracked.

Defective Sprays Prompt Recall of 350,000+ Inhalers

Boehringer Ingelheim announced a voluntary recall of over 350,000 Combivent Respimat (ipratropium bromide, albuterol) inhalation sprays due to a defective delivery system.

Obesity Drug Labeling Updated with New Interaction, Side Effect

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xenical (orlistat; Genentech) regarding new drug interactions and adverse reaction updates to its labeling.

Tainted Weight Loss, Men's Vitality Supplements Recalled

Blue Square Market, Inc. announced voluntary recalls of Kaboom Action Strips and LiDa DaiDaiHua due to the presence of undeclared active ingredients.

New Warning on Weight Loss Supplement Containing Hidden Drug

The Food and Drug Administration (FDA) is warning consumers not to buy or use Achieving Zero, a supplement marketed for weight loss.

Increased Thrombosis, Stroke Risk With Some LV Assist Devices

The Food and Drug Administration (FDA) is alerting healthcare providers, patients, and caregivers on serious adverse events linked to left ventricular assist devices (LVADs), including the HeartMate II Left Ventricular Assist System (Thoratec Corporation) and the HeartWare Ventricular Assist System (HVAD) manufactured by HeartWare, Inc.

Infusion Pump Pulled Due to Hacking, Cybersecurity Concerns

The Food and Drug Administration (FDA) has issued an alert regarding cybersecurity vulnerabilities with Hospira's Symbiq Infusion System.