From the category archives:

MedWatch

Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement – Risk of Lead Poisoning

September 26, 2014

Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice [...]

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Xolair (omalizumab): Drug Safety Communication – Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

September 26, 2014

FDA approves label changes after review of a five year safety study. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Potassium Chloride Injection (Baxter): Recall – Shipping Carton Mislabeling

September 17, 2014

Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall – Particulate Matter

September 12, 2014

Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Pharmacy Creations Certain Products: Recall – Potential Non-Sterility

September 5, 2014

Compromised sterility of a product may lead to risk for infection This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall – Lack of Assurance of Sterility

September 2, 2014

Compromised sterility of a compounded preparation may lead to risk for infection. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Dermatend Original and Dermatend Ultra: Recall – Safety Concerns

September 2, 2014

Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch [...]

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DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall – May Reverse Directions After Surgery

August 28, 2014

Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take [...]

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Sterile Convenience Surgical Packs by Customed, Inc.: Recall – Potential Loss of Sterility

August 26, 2014

Potential adhesion defect which may lead to infection. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall – Possibility of Mold

August 22, 2014

Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice [...]

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