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FDA

LL Bakery, Inc. Announces the Recall of White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish for Undeclared Milk Allergens

May 21, 2013

LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen “milk”, in the whey powder listed in their ingredient statements. People who have an allergy or severe sensitivity to milk run the risk of [...]

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Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall – Particulate Matter In Vials

May 21, 2013

Particulate matter in parenteral drugs has been recognized as a potential health hazard. 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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Eco-Cuisine Recalls Product Because of Possible Health Risk

May 20, 2013

Eco-Cuisine of Boulder, Colorado is recalling all lots of T3314 Basic Brownie Mix, T3333 Betty Brownie Mix with Vanilla, T3388 Ground Beef Style Quick Mix, T3394 Sausage Style Quick Mix, T3416 Chocolate Cookie Mix, T3417 Lemon Muffin Mix, and T3418 English Scone Mix, CM25COOK Basic Cookie Mix 25 lb. bag, CM25MUFF Basic Muffin Mix 25 [...]

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Sandoz US Announces Voluntary Nationwide Recall of two lots of Methotrexate Sodium, USP, Injectable Vials, 25mg/mL, 40mL vials

May 20, 2013

Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free. This is [...]

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Precautionary Recall Issued For Pre-Packaged Texas Gulf Shrimp

May 20, 2013

Galveston Shrimp Company has issued a precautionary voluntary recall of its pre-packaged Texas Gulf Shrimp due to foreign material found in a bag. The pre-packaged bags are shipped to HEB Stores. Customers who recently purchased pre-packaged Gulf Shrimp are encouraged to check their refrigerators and/or freezers. This is a summary of a recall issued by [...]

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Abbott Diabetes Care: Class 1 Recall – FreeStyle InsuLinx Blood Glucose Meters – Risk of Incorrect Test Result

May 20, 2013

Incorrect test results at extremely high blood glucose levels. 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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All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall – Lack Of Sterility Assurance

May 18, 2013

If a drug product marketed as sterile has microbial contamination, patient is at risk of serious 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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FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

May 18, 2013

The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients. This is a summary of a Press Release issued by [...]

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Compounded Prescription Therapies By Pentec Health Inc.: Recall – Lack Of Sterility Assurance

May 17, 2013

Patients are at increased risk of infection in the event a sterile product is compromised. 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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FDA seeks preliminary injunction against New York fish manufacturer

May 17, 2013

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to [...]

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