August, 2011CVS Agrees to $45,000 Civil Penalty for Failing to Report Drawstrings in Children’s Jackets

The U.S. Consumer Product Safety Commission (CPSC) announced today that CVS Pharmacy, Inc., of Woonsocket, R.I., has agreed to pay a civil penalty of $45,000. The settlement agreement has been provisionally accepted by the Commission unanimously (5-0).

PTSD Drug Found Ineffective

A drug used to treat post-traumatic stress disorder in veterans isn’t effective in reducing the overall severity of the condition, according to a new study in the Journal of the American Medical Association. The medication did not have a significant effect on anxiety and depression, researchers reported. The clinical trial, which took place over six months, found that the antipsychotic medication risperidone was no more effective than a placebo at preventing PTSD symptoms. Out of the 247 patients surveyed for …

Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review – Possible Increased Risk of Death

Audience: Pediatrics, Endocrinology [UPDATED 08/04/2011] FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. In its analysis of the SAGhE study, FDA identified…

Vasopressin Injection USP, Multiple Dose Vials: Recall – Sub-Potency

Audience: Risk Manager, Pharmacy ISSUE: American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the Retail/Hospital level. This product recall was initiated by American Regent, Inc. because…

Black & Decker Agrees to $960,000 Civil Penalty for Failing to Report Defective Grasshog XP Weed Trimmer/Edgers

The U.S. Consumer Product Safety Commission (CPSC) announced today that Black & Decker (U.S.) Inc., of Towson, Md., has agreed to pay a civil penalty of $960,000. The penalty agreement has been provisionally accepted by the Commission (5-0).

NexTorch Recalls Flashlight Batteries Due to Fire Hazard

Batteries can overheat and rupture, posing a fire and burn hazard to consumers.

LexisNexis® Legal News Podcast for Aug 3, 2011

Judges appointed by President Obama decline to recuse themselves in a Patient Protection and Affordable Care Act case, and, the 10th Circuit finds a city is not entitled to immunity in an unlawful tying lawsuit. Hear these and other stories from Lexis…

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Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects

Audience: OBGYN, Pharmacy, Infectious Disease ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set…

Cloud Engines Recalls Pogoplug Video File Sharing Device Due to Fire Hazard

The unit can overheat or catch fire, emitting excessive heat, sparks, smoke or flames.

LexisNexis® Legal News Podcast for Aug 2, 2011

Supreme Court review is sought of the Patient Protection and Affordable Care Act’s individual mandate, and, the Neurontin MDL judge refuses to set aside a $142 million RICO verdict. Hear these and other stories from LexisNexis® Mealey’s™ Publicati…

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