From the category archives:

MedWatch

Injectable Products by Mylan: Recall – Presence of Particulate Matter

April 24, 2015

Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. 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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Bupivacaine HCl Injection by Hospira: Recall – Iron Oxide Particulate In Glass Vials

April 24, 2015

Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue. 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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Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall – Not Cleared for Marketing

April 22, 2015

The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015 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 [...]

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Mucinex Fast-MAX Products: Recall – Incorrect Labeling

April 22, 2015

Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. 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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Flurbiprofen-Containing Topical Pain Medications: FDA Alert – Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication

April 17, 2015

Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died. 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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VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall – Potential for Separation of Tube from Hub

April 16, 2015

Separation could result in required intervention to prevent permanent impairment or damage. 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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Intravenous (IV) Solutions (Select Lots) by Baxter: Recall – Potential Presence of Particulate Matter

April 10, 2015

Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. 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 [...]

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Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall – Lack of Sterility Assurance

April 2, 2015

Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada. 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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Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed

March 31, 2015

Risk of potentially life-threatening allergic reactions. 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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Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication – New Reprocessing Instructions Validated

March 26, 2015

If not properly reprocessed patients may be exposed to serious infections. 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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