August, 2009Ibuprofen (Unapproved) topical drug products

Audience: Consumers, pharmacists FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. …


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U.S. Gives Thumbs Up to Controversial Cervical Cancer Vaccine Gardasil

They say where there is smoke, there is fire, but despite continued questions swirling around the Merck & Co. cervical cancer vaccine Gardasil, government regulators are standing firmly behind the drug.

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CPSC Announces the Swearing In of Two New Commissioners

Robert S. Adler and Anne Northup were sworn in this week as Commissioners of the U.S. Consumer Product Safety Commission (CPSC). Mr. Adler and Mrs. Northup were nominated by President Barack Obama on May 5 and July 30, 2009, respectively. Both were confirmed by the Senate on August 7, 2009.

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Cloth Books Recalled by Sterling Publishing Co. Inc. Due to Strangulation Hazard

A string attaching a ball to the book can become entangled in the basketball hoop element, posing a strangulation hazard to young children.

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FDA Warns Companies About Marketing Unapproved Topical Pain Relievers

The Food and Drug Administration today is warning companies about selling over-the-counter topical pain relief products containing ibuprofen, which have not been reviewed or approved by the agency.

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Spinal Cement Injuries at Issue in New Lawsuit

A Texas man has filed a lawsuit against the maker of a brand of spinal cement, accusing the product of leaking into his pulmonary arteries and causing him to suffer respiratory problems following surgery.

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After Two More Infant Deaths, CPSC Re-Issues 2008 Simplicity Bassinet Recall

Nearly a year after the recall of nearly a million Simplicity 3-in-1 and 4-in-1 bassinets was first announced, the recent deaths of two more infants in the defective beds have prompted officials to re-issue the recall.

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FDA Proposes New Rules for Reporting of Medical Device and Drug Problems

The Food and Drug Administration is considering requiring makers of drugs, biologics, and medical devices to report problems with the products once they are available to patients to the FDA in electronic form rather than on paper.

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Two Additional Infant Deaths Prompt Re-announcement of Simplicity “Close-Sleeper/Bedside Sleeper” Bassinets

The U.S. Consumer Product Safety Commission (CPSC) is once again urging all parents and caregivers to immediately stop using convertible “close-sleeper/bedside sleeper” bassinets manufactured by Simplicity Inc., of Reading, Pa. CPSC has learned of two additional infant deaths since the August 2008 safety alert and recall announcements that notified consumers of two infants who had strangled in their Simplicity bassinets. To date, CPSC is aware of four infants who have died in the close-sleeper bassinets.

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1.5 Million Durabrand DVD Players Recalled due to Fire, Burn Hazards

About 1.5 million Durabrand DVD players sold at Wal-Mart stores nationwide have been recalled because they may overheat, posing a risk of fire and burns to consumers, the Consumer Product Safety Commission said.

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