RSSArchive for June, 2010

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Benicar (olmesartan): Ongoing Safety Review

FDA evaluating data in which type 2 diabetes patients taking Benicar had a higher rate of death from cardiovascular cause compared to placebo. FDA has not concluded that Benicar increases the risk of death.

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Vitamin D Supplement Products: Medication Use Error

Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant.

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McNeil Consumer Healthcare Over-The-Counter Products: Recall

UPDATED 06/17/2010. Recall expanded to include product lots of Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels.

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Magic Power Coffee: Undeclared Drug Ingredient

Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.

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Mylotarg (gemtuzumab ozogamicin): Market Withdrawal

Drug failed to demonstrate clinical benefit to patients enrolled in trials.

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Tamiflu: Counterfeit Product Sold on Internet

Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.

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Youth Tiara Recalled by Wilton Industries Due to Lead Exposure Hazard

The tiara contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

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Seven Manufacturers Announce Recalls to Repair Cribs to Address Entrapment, Suffocation and Fall Hazards

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC), with the cooperation of seven firms, is announcing voluntary recalls of more than two million cribs to address drop-side hazards and other hazards that affect the safety of young children. The recalling firms are providing consumers with free repair kits to immobilize the drop sides [...]

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Simmons Recalls to Repair Drop-Side Cribs Due to Entrapment, Suffocation and Fall Hazards

The cribs’ drop sides can malfunction, detach or otherwise fail, causing part of the drop side to fall out of position, creating a space into which an infant or toddler can roll and become wedged or entrapped, which can lead to strangulation or suffocation. A child can also fall out of the crib. Drop-side incidents [...]

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Million Dollar Baby Recalls to Repair Drop-Side Cribs Due to Entrapment, Suffocation and Fall Hazards

The cribs’ drop sides can malfunction, detach or otherwise fail, causing part of the drop side to fall out of position, creating a space into which an infant or toddler can roll and become wedged or entrapped, which can lead to strangulation or suffocation. A child can also fall out of the crib. Drop-side incidents [...]

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LaJobi Recalls to Repair Bonavita, Babi Italia and ISSI Drop-Side Cribs Due to Entrapment, Suffocation and Fall Hazards

The cribs’ drop sides can malfunction, detach or otherwise fail, causing part of the drop side to fall out of position, creating a space into which an infant or toddler can roll and become wedged or entrapped, which can lead to strangulation or suffocation. A child can also fall out of the crib. Drop-side incidents [...]