The independent data monitoring committee (IDMC) concluded that the 2 trials (AMARANTH and DAYBREAK-ALZ) investigating the treatment in mild Alzheimer's disease dementia, were not likely to meet their primary endpoints of change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale.
Two lots of naloxone hydrochloride injections, USP have been recalled by Hospira, Inc., due to concerns regarding the presence of particulates on the syringe plunger.
A physician report indicates that 4 placebo (non-hormonal) capsules were placed in the first 4 days of therapy instead of active capsules.
A number of kratom-containing dietary supplements are being recalled and destroyed by the manufacturer stated the US Food and Drug Administration.
After public opposition, the DEA has withdrawn its plan to classify the kratom plant as a schedule 1 substance.
Action taken after pharmacist found a heart drug among Effexor XR, FDA says.
Company issues recall due to defects in product packaging
All lots of the new anemia drug peginesatide have been recalled because of severe, sometimes fatal, hypersensitivity reactions.
At least one lot of Zicam Extreme Congestion Relief nasal gel has tested positive for Burkholderia cepacia.
Qualitest's Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg may contain tablets with a higher than labeled dose of acetaminophen.
Drug manufacturer recalls 41 lots of atorvastatin calcium tablets due to potential contamination with small glass particles.
Two additional recalled products from the New England Compounding Pharmacy -- the facility that produced the steroids responsible for the ongoing fungal meningitis outbreak -- have tested positive for bacterial contamination.
Ameridose, the sister company to the pharmacy that distributed tainted steriods responsible for the ongoing fungal meningitis outbreak, is recalling all of it's products.
Health officials have confirmed the presence of the fungus Exserohilum rostratum in unopened recalled steroid vials from New England Compounding Pharmacy.
Methylprednisolone acetate from a New England compounding pharmacy is believed to be the source of a fungal meningitis outbreak that could affect people in 23 states.
Drug manufacturer Qualitest has issued a nationwide voluntary recall of one lot of hydrocodone bitartrate and acetaminophen 10mg/500mg tablets due to potentially over-sized tablets.
The FDA is warning against using Reumofan Plus, a Mexican product marketed as a "natural" dietary supplement for pain relief, because it may contain unlabeled, potentially harmful pharmaceuticals.
The FDA is notifying all physicians and healthcare organizations of the recall of all sterile products sold by Franck's Compounding Pharmacy since November 2011 due to the possibility of lack of sterility.
Prefilled glass cartridges of hydromorphone HCI injection 1 mg/mL manufactured by Hospira may contain more than the labeled 1 mL fill volume.
Franck's Compounding Pharmacy has recalled one additional lot of triamcinolone acetonide PF 80mg/mL.
American Regent has issued a nationwide voluntary recall of epinephrine injection, 1:1000, 1mL ampules after concerns that visible particulates in some ampules could cause adverse events if administered intravenously.
American Regent has issued a nationwide voluntary recall of three lots of Cyanocobalamin Injection 1,000mcg/mL (1mL vial), because cracks can form in them bottom and sides of some vials.
Eagle Pharmaceuticals has issued a voluntary recall of four lots of Argatroban Injection 50mg/50mL (1mg/1mL) due to a potential for visible particulates.
Glenmark Generics Inc. has issued a voluntary nationwide recall of seven lots of the oral contraceptives norgestimate and ethinyl estradiol, after consumers reported that the tablets in some packages were in reverse order.
American Regent has issued a nationwide voluntary recall of Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5mL vials.
McNeil Consumer Healthcare is voluntarily recalling seven lots of Infants' Tylenol Oral Suspension, 1oz Grape, distributed nationwide in the U.S.
The drug-maker Novartis has issued a voluntary nationwide recall of the over-the-counter (OTC) products Exedrin, Bufferin, Gas-X Prevention and NoDoz, after concerns that these medications may contain "stray tablets, capsules or caplets" from other Novartis drugs.